Autoimmune and inflammatory diseases are key areas that we believe have plenty of unmet need and growth potential over the next decade. The unprecedented availability of private capital has enabled many private companies to be built around treatments for many patient indications in these areas. Targets that offer more specific immune modulation (and could therefore improve the risk/benefit profile) or more convenient routes of administration (through oral or extended activity formulations) are of particularly high interest to our team in the years ahead.
Programs targeting specific tumor mutations have attracted a lot of capital over the past decade, but enthusiasm has been tempered by recent lukewarm launches, FDA scrutiny around the accelerated path to approval, and uncertainties around development after the Inflation Reduction Act.
However, we continue to be impressed by the progression of the underlying science and higher-than-average odds of clinical success for such programs. Notably, we have become increasingly focused on targets that suggest high efficacy and low competition, as well as oncology indications where there is a high and undisputable unmet medical need. In our view, innovations with these characteristics are better positioned to navigate the evolving challenges in the precision oncology space.
Unlike conventional chemotherapy treatments that are toxic to healthy cells, antibody drug conjugates deliver chemotherapy agents directly to cancer cells. This is made possible by a “linker” that attaches a toxin to a monoclonal antibody that then binds to a specific target expressed on a cancer cell. By binding to the target, the ADC is able to release the cytotoxic drug directly into the cancer cell and avoid harming healthy cells.
The ADC modality has produced several important drugs of the past decade, and we are impressed with recent clinical updates in new cancer indications. The space continues to improve upon the safety and efficacy profile of ADC-based drugs (and the range of treatments that they may be able to offer) through progress in linker chemistry, conjugation technology, and payload (i.e., toxin) selection. We believe ADCs will solidify as a core treatment in the standard of care for many cancers, potentially across multiple lines of treatment given innovations in targeting and payload choices.
Radiopharmaceuticals, or radioligand therapies, are another targeted form of cancer treatment that deliver radiation to specifically targeted cancer cells, with minimal effect on surrounding healthy tissue. Momentum in the space has increased in recent years driven by encouraging clinical data and strong recent launches targeting neuroendocrine tumors and prostate cancer. In our view, this innovation, despite recent progress, is still in the early stages and the modality will continue to build on the precision oncology and ADC themes.
Further, radiopharmaceuticals have historically been hampered by the complexity of their commercial execution, but we believe recent advances and a growing market infrastructure should help overcome these challenges and increase pharma interest in the space.
CAR T-cell-based therapies have dramatically changed the standard of care and prospects of patients who suffer from a variety of blood cancers. The next wave of innovation in this space could improve upon the complicated logistical challenges of existing autologous approaches (which use cells from the patient). Novel manufacturing technologies could significantly shrink the process timeline or enable an off-the-shelf, allogeneic approach (which would broaden the source of cells beyond the patient).
Targeting solid tumors with these cellular therapies has proven to be challenging, and there is significant room for progress in this area. We are keeping an eye on novel CAR T-cell therapies that are armored with additional mechanisms that have the potential to survive the defenses of tumors in the tumor microenvironment. In our view, recent preliminary data from T-cell receptor (TCR)-targeting modalities — in both soluble (TCR engagers) and cell therapy (TCR-Ts) formats — combined with proof-of-concept clinical data from public companies working on this modality show encouraging progress. As we continue to explore the space, we are excited by second-generation products being built by multiple private companies focused on this innovation.
Protein degradation, through either proteolysis-targeting chimeric technologies (PROTACs) or molecular glues, is an area of high activity in the private markets. Unlike traditional small-molecule inhibitors that require an accessible catalytic site to block the activity of a protein, degraders can leverage any binding pocket or, in some cases, no binding pockets at all. As such, the modality can target previously undruggable proteins. In particular, the PROTAC field has advanced tremendously in recent years. We are now exploring the nascent space of molecular glues, which could see its historically challenging drug design issues helped by new breakthroughs in the field.
Inconsistent sampling can lead to incorrect conclusions about reaction progress, yield, and quality. Therefore, accurate and reproducible sampling is crucial, especially when scaling up chemical processes.
This application note is based on research carried out by a team of scientists at Pfizer. They evaluated the sampling reproducibility of the ReactALL™ system with SmartCap™ technology. Using diphenyl ether in acetonitrile and a mixture of diphenyl ether and sodium tosylate in toluene, the results demonstrate consistent and reliable sampling performance, comparable to manual sampling. Furthermore, the results were achieved with minimal variability in both homogeneous and heterogeneous mixtures.
This application note addresses key questions in development and formulation of GLP-1 analogues such as liraglutide and semaglutide. It explores which oligomeric states are present and how the composition changes under different formulation conditions. Additionally, it investigates the presence of aggregates and how pH and ionic strength impact their formation. To answer all of these questions, multi-angle light scattering (SEC-MALS) was used to identify, quantify, and characterize the monomeric, oligomeric, and aggregate states of GLP-1 analogs under native and denaturing conditions.
Leaders in chemistry increasingly recognize AI and advanced computing technologies as tools that can bring the speed, scalability, and efficiency needed to address global challenges. However, many chemists don’t know where to start when it comes to leveraging these transformative technologies.
Download this resource to discover practical ideas, solutions, and support systems for implementing these tools. By boosting human productivity with technology at every stage of the scientific method — from hypothesis generation to experimentation and analysis — computational tools can compress decades of research into years.
We evaluated the ability of Pyxis™, a machine learning (ML)-based cloud platform, to annotate metabolite identity and absolute concentrations in diverse sample matrices. Absolute quantification is achieved by combining the signal from matrix-independent calibrators (StandardCandles™) with an ML approach, which obviates the requirement for stable isotope-based calibration curves.
In this study, we used conventional stable isotope-labeled standard methodology as a benchmark. The efficient and rapid performance of Pyxis using unprocessed MS data, demonstrates its comparative advantage over the traditional approach. This highlights the potential of this innovative approach to revolutionize metabolomics. Pyxis can facilitate metabolite analysis across biological discovery, drug development, and bioprocessing applications, regardless of the sample type or the researcher's experience.
Approximately 80% of proteins lack enzymatic activity or an obvious active site for traditional small molecule drugs to block. This thwarts the development of therapies for diseases associated with these proteins.
To take on these “undruggable” proteins, researchers are developing complex drug structures like proteolysis-targeting chimeras (PROTACs) and other chimeric targeted protein degraders that challenge the traditional rules of drug design. Due to their structural complexity, collaborations are essential to accelerate the development of targeted protein degraders to meet critical unmet needs.
Find out how machine learning is empowering a new approach to Design of Experiments (DOE) that delivers better results with 50-80% fewer experiments than conventional methods. You can quickly find the optimal composition, chemistry, or processing parameters to achieve commercial performance goals. Answering such questions is key to the design of formulations, chemicals, materials, and biopharmaceuticals.
You will learn how machine learning enables adaptive experimental design, which focuses effort on those routes most likely to be successful. Since experimental costs associated with a typical industrial R&D project run to hundreds of thousands of dollars, the resulting reductions in workload deliver a significant return on investment.
Drug development continues to advance understanding about causes of disease as well as to innovate therapeutic modalities. Yet the process remains time intensive, costly, and high risk. The average drug takes over 10 years and $1 billion–$2 billion to be approved for clinical use— yet 90% of new drugs reaching Phase I clinical trials ultimately fail to reach approval.
This high risk of failure, along with the substantial investment of time, labor, and financial resources put into every new drug candidate, poses a persistent challenge for drug developers. To ensure the efficient use of development resources and the creation of safe, effective, and reliable products for patients, drugmakers must take steps to de-risk development at every step. In this e-book, learn about three tools that drug developers can use to successfully navigate the journey from candidate compound to clinical success.
Scientific research always depends on finding the right test system – this is especially true in absorption, distribution, metabolism, excretion, and toxicity (ADME-Tox) testing, as quality and consistency are paramount. With so many options available, selecting the ideal test system can be a challenge.
This e-book offers an in-depth look at ADME-Tox test products, including hepatocytes, subcellular fractions, recombinant enzymes, and advanced multicellular systems. The guide explores BioIVT’s portfolio of high-quality, ethically sourced products, as well as expert advice on the advantages and limitations of each test system.
According to industry experts, the purification step is absolutely essential to the commercialization of any mRNA therapeutic. As the field of mRNA therapeutics advances, there is now a growing focus on refining, optimizing, and standardizing manufacturing processes, particularly the downstream processing steps. This phase is crucial for ensuring that any mRNA product is pure, stable, and effective.
Key differences between mRNA and more traditional biologics necessitate specialized purification methods to remove impurities and meet still-emerging quality standards. The efficiency and scalability of these processes could make or break the successful commercialization of current and future mRNA therapies. Download this resource to stay on the cutting edge of mRNA therapeutic development and manufacturing.
Various plastic recycling measures are being implemented in response to growing awareness about needing to establish a carbon-free and recycling-oriented society. Plastic recycling primarily involves one of these two processes: "material recycling," which uses waste plastic directly in the form of plastic as a raw material for reuse products, and "chemical recycling," which chemically decomposes waste plastic for reuse as a raw material in new products.
In this eBook, we highlight our analytical solutions, including structural analysis, mechanical properties, impurities analysis, and multifaceted evaluations used in the plastic recycling process.
Given stringent regulatory guidelines regarding the presence of nitrosamines, drug innovators and manufacturers must consider control of these impurities not only in the active pharmaceutical ingredient (API) chemical process, but also in their starting materials, solvents, and more. A plan for control early in development is critical to maintaining product quality and safety. Partnering with the right CDMO can help mitigate risk throughout the process.
Amorphous materials, known for improving solubility and dissolution rates, face stability challenges, losing their beneficial properties. Stabilizing these materials in a polymer matrix through amorphous solid dispersions helps retain their advantages. By embedding active ingredients in polymers, the stability and solubility are enhanced, with formulation optimization achieved by adjusting solvents, drug loads, and temperature profiles. Polymers also exhibit different thermal behaviors, such as LCST (Lower Critical Solution Temperature), which are important for developing controlled drug delivery systems. Automated systems, such as the Crystal16® , enhance efficiency in drug formulation by determining solubility curves and dissolution rates through transmissivity measurements, which also help identify key processes like micelle formation.
Continuous chemical manufacturing technology has been in use for more than 100 years producing high-volume commodity chemicals. However, it was not until the early s that the technology caught the attention of the pharmaceutical industry in a significant way, and it has since revolutionized the production of pharmaceuticals. In this article, Matthew Bio, Chief Scientific Officer at Cambrex, discusses how continuous manufacturing has become integral to the pharmaceutical industry.
This white paper offers a comprehensive guide on optimizing the performance of analytical balances by addressing variables that impact accuracy, stability, and speed. It specifically focuses on how Sartorius' Cubis II balances overcome challenges such as electrostatic discharge (ESD), temperature fluctuations, and pressure changes. Additionally, it emphasizes the importance of proper cleaning practices to maintain balance, accuracy and reliability.
Readers can expect to gain detailed insights into the key factors influencing analytical balance performance and practical strategies for mitigating these effects using Sartorius' advanced technology. The white paper also provides specific examples of how the Cubis II balances enhance laboratory efficiency and measurement precision.
Designing effective ADCs is a complex task, requiring the precise coordination of antigens, antibodies, linkers, and payloads. The challenge lies in targeting tumor cells while avoiding damage to normal tissues, ensuring the therapeutic payload is delivered accurately and efficiently.
This white paper, authored by Dr. Kishore Hotha, provides a comprehensive overview of ADCs, covering the fundamental technical aspects, regulatory challenges, and clinical insights. It includes detailed discussions on antibody selection, linker-payload compatibility, and the latest advancements in ADC technology. Readers will also gain insights into recent ADC approvals and the status of late-stage clinical trials for cancer-specific ADCs
Processing conditions can influence a polymer's performance as much as its chemical formulation. The material's thermal and shearing history and its fillers, fibers, stabilizers, or other additives help determine many of its properties. Laboratory analysis can help optimize polymer processing conditions, diagnose issues in an existing process, and ensure consistent quality in the end products.
TA Instruments offers an array of thermal, rheological, and mechanical analysis instruments that can help identify potential trouble spots during and after processing. Rapid, reliable testing can minimize wasted material, product defects, and equipment downtime, while also ensuring that products meet consistency and durability standards.
In the world of drug discovery, countless potential treatments languish in the “valley of death” that separates promising candidate compounds from clinical implementation. Investigators face high costs, limited technology access, lengthy timelines, and regulatory hurdles. But strategic NIH programs are bringing together government, industry, and academic resources to overcome these challenges and deliver new drugs to the patients who need them most. This white paper explores the benefits of these partnerships, with insights and examples from NIH and Curia experts who have been involved for years.
Over the past decades, the materials sector has come to rely more and more on data and analytics. With the heavy investments made in materials informatics, this means materials science is one of the applications uniquely suited to undergo an R&D digital transformation that harnesses the full power of new AI and cloud high-performance computing (HPC) tools.
In this free white paper, hear from leading materials innovators and learn how AI and HPC are accelerating materials discovery and enabling companies to bring products to market faster.
Surface Plasmon Resonance (SPR) is an invaluable technique that generates information rich data for a variety of biomolecular interactions. Researchers can utilize SPR to understand biological pathways and to develop and characterize a range of potential therapeutics to treat disease and illnesses. These interactions include those occurring with and between the major classes of biological macromolecules along with small molecules or drugs.
This article is focused solely on using SPR to study biomolecular interactions involving small molecules binding to proteins. To provide key information about these interactions, many researchers rely on SPR, which is a widely used technique for the determination of kinetics and affinity. This type of experiment is often carried out to aid in the development of small molecules as potential therapeutics for disease. This white paper highlights some articles that researchers have published using Reichert’s SPR systems for investigating low molecular weight molecules interacting with proteins.
One of the key challenges of pharmaceutical development and manufacturing is transferring lab processes to equipment suitable for large scale production (from kgs to hundreds of kgs). Upon transitioning in larger vessels, many parameters are impacted (scale-dependent variables) and the consequences of these changes are often difficult to predict. For these reasons, a thorough understanding of the synthetic process beyond the simple chemical reactivity that will encompass engineering aspects, is of paramount importance.
For this reason Olon has invested and implementing a large scale development mindset that can contribute to design synthetic process that will consider these variable during early phase of development.
Powders are the functional building blocks of lithium-ion batteries and the ideal raw materials for their electrodes because they provide a high surface area for charge transfer. Understanding powder properties is pivotal to optimize electrode fabrication.
In this white paper, learn how powder rheology can help battery scientists and engineers monitor fundamental powder properties for electrode function and identify dry powder processing conditions that lead to better lithium-ion batteries.
This e-book contains a wide variety of analysis methods and applications for quality control of hydrogen during its various stages of development and storage. This includes various analysis methods for hydrogen itself as well as methods for the catalysts that are used to manufacture hydrogen and the hydrogen carriers and tanks that hydrogen is stored in. As hydrogen’s use as a fuel slowly becomes more common, quality control will become more important. We hope that these applications are useful in tackling that challenge.
There’s no question that artificial intelligence (AI) is now embedded in the drug discovery process at a growing number of companies. Machine learning, deep learning, and generative AI can help scientists generate structures for new drug candidates and explore protein-ligand binding before starting any experiments in a wet lab.
Use cases for AI in drug discovery are still evolving, and AI-powered drug ideation still must overcome many hurdles before it becomes commonplace and reliable. Here’s the latest on how AI supports drug discovery.
70% of all solid materials produced in chemical industry are obtained by crystallization or precipitation from solution. The solubility of your compound in organic solvents or water plays an important role when designing or optimizing your crystallization process. Knowing the solubility will allow you to select suitable solvents for the different crystallization methods. Alcohols for example, are often used as co-solvents in aqueous solutions altering the solubility and other crystal attributes. In this app note, we exemplify how measured solubility data in various water-alcohol binary solvent systems and the Jouyban–Acree model can be used to predict solubility as a function of temperature and solvent composition. Predicting the solubility in various binary solvent systems makes it easier to select the most appropriate solvent system to optimize the crystallization process. In addition, predictive technology provides us with a wide range of information with limited experimental data and resources.
Trends in the global R&D pipeline suggest that the pharmaceutical industry is navigating a landscape of competing factors. Though new pharmaceuticals are moving to market faster than ever, developers need time to optimize formulation for the sensitive, high-potency active ingredients that dominate the current pipeline of drug candidates.
The challenge of balancing speed and thorough development can be solved by choosing hard-shell capsules as a dosage form. Manufacturers can dose small amounts of pure active pharmaceutical ingredients (APIs) or simple blends directly into hard capsules. Learn how micro doses less than 5 mg or low doses, which can range from 5 mg to 100 mg, delivered in hard capsules are an accessible solution that enables manufacturers to bring new medicines from R&D to market more quickly.
Downstream purification and enrichment of full AAV capsids for gene therapy products is typically accomplished by ion-exchange chromatography (IEX). While the UV260/UV280 ratio is often used to control pooling, it does not afford deep insight into accurate empty and full titers or discriminate desirable vectors from impurities. Only when detailed offline analysis of fractions is complete does that information make its way back to process developers or manufacturing teams.
Real-time multi-angle light scattering (RT-MALS) operates in-line with bench-scale FPLC systems to monitor and quantify critical quality attributes (CQA) and identify impurities. RT-MALS provides immediate results for CQA values and enables optimized control over collection of the purified product pool. In addition, with no additional effort, RT-MALS supports the acquisition of invaluable process knowledge.
The increasing complexity of small molecules entering the drug development pipeline is a real challenge, not least because the synthetic routes to make them are often long. This adds to the issues facing process chemists as they look for a cost-effective and high-yielding synthesis for scale-up and commercialisation. Supply chain complexity is a knock-on concern that can also add to costs. Taken together, these issues mean there is a significant risk that development timelines may not be met.
As a result, computer-aided synthesis design technologies (CDSTs) have been developed to assist in finding the most effective synthetic route for a given molecule. In this white paper, we look at how our two companies have worked together to develop a retrosynthesis process that meets the needs of process chemists in Lonza’s Preclinical Route Design group. It combines Elsevier’s Reaxys technology with Lonza’s real-world experience and supply chain insights. The result is a route scouting service that is already helping to mitigate API complexity and accelerate small molecule drugs’ route to market.
Providing a safe and healthy workplace is a core responsibility of every employer across the chemical and pharmaceutical industries. However, product development and production often involves inherent risks to people, processes, and the environment. Properly addressing these risks requires robust safety practices.
Tools and techniques that allow for automation and a better understanding of research, development, and manufacturing processes help to establish and sustain a culture of safety while also speeding project timelines. Learn how some chemical and pharmaceutical companies have used automation to mitigate risk.
Lithium-ion batteries generate myriad data at all stages of production—from materials discovery to electrode and cell manufacturing. Data collected and aggregated in one stage facilitates decision-making for the next, increasing the importance of learning as much as possible about each data set along the way.
Learn how data analytics can be applied to different stages of lithium-ion battery manufacturing to achieve quick development, high product quality, maximum production efficiency, lower costs, and minimal waste.
Drug development continues to advance understanding about causes of disease as well as to innovate therapeutic modalities. Yet the process remains time intensive, costly, and high risk. The average drug takes over 10 years and $1 billion–$2 billion to be approved for clinical use— yet 90% of new drugs reaching Phase I clinic al trials ultimately fail to reach approval.
This high risk of failure, along with the substantial investment of time, labor, and financial resources put into every new drug candidate, poses a persistent challenge for drug developers. To ensure the efficient use of development resources and the creation of safe, effective, and reliable products for patients, drugmakers must take steps to de-risk development at every step. In this e-book, learn about three tools that drug developers can use to successfully navigate the journey from candidate compound to clinical success.
Targeted protein degradation can be used to achieve efficacy in various disease contexts where other therapies fail. PROTACs® are unique, high-molecular-weight compounds that facilitate the labeling of a target protein, marking it for removal by cellular degradation machinery. These molecules bring two proteins together, and action dependent on the formation of a three-part complex introduces challenges during drug discovery and development.
Learn how to identify PROTAC candidates using DNA-encoded libraries and explore specialized screening and analytical techniques for target validation, compound optimization, mechanistic studies, and in vivo testing.
PROTAC® is a registered trademark of Arvinas Operations, Inc., and is used under license.
Octreotide acetate is a therapeutic octapeptide analog of the naturally occurring hormone somatostatin. First approved for use in the United States in , this synthetic peptide agonist is primarily used to treat adults with acromegaly. Most patients with acromegaly require life-long use of hormone therapy. New therapies such as oral formulations promise better disease control and quality of life for patients, but require 30-60 times higher octreotide ace¬tate concentrations, thus putting demand on complex active pharmaceutical ingredient manufacturers to cost-effectively scale production.
Learn how one pharmaceutical manufacturer used solid phase peptide synthesis to scale up octreotide acetate production 15-fold, producing validated product from the new process within 22 months.
The food industry is shifting to meet increasing consumer preference for allergen-free, plant-based, or flexitarian diets. Plant-based milks, such as almond and oat milk, have gained significant market share, and so have gluten-free foods—even among individuals without sensitivities. But making an ideal alternative milk or bread that doesn’t sacrifice taste or texture is hard.
Learn how focusing on choosing high-quality ingredients, fortifying formulations with essential bioavailable nutrients, and using additives like gums to achieve the desired texture and taste helps food manufacturers make allergen-free food taste delicious.
More than ever, scientists need new technologies to help solve many of the most pressing issues facing society like reversing climate change, addressing food insecurity, and developing lifesaving therapeutics. Fundamentally, these problems are chemistry and materials science challenges, and some will require the transformational power of a scaled quantum computer. While we are on a path to engineer a quantum supercomputer, we are also making investments in High-performance computing (HPC) and AI to empower researchers to accelerate scientific discovery and make rapid progress toward impactful solutions for our most pressing problems today.
In this whitepaper, we explore the recent breakthroughs in molecular simulation, which provide exciting new possibilities for computational chemists and materials scientists. We also discuss the latest advances in HPC and AI and describe how to start using Azure Quantum Elements today.
Free energy perturbation (FEP) calculations are the gold standard for computationally assessing binding affinities of small molecules to their target proteins. In many cases, calculated binding affinities approach the accuracy of experimental measurements, and data from known molecules facilitate predictions for similar uncharacterized molecules. When used in drug discovery, FEP can expedite the search for more effective drug candidates.
A demonstration run using CDK9 inhibitors narrowed a large set of molecules down to a short list of promising candidates for laboratory testing. FEP calculations identified one previously unknown variant that showed even higher binding affinity than the "hit" molecule from which it was derived.
Today, more than ever, the advancements in Artificial Intelligence (AI) and Machine Learning (ML) have redefined the ways in which R&D organizations are able to analyze, interpret, and leverage large volumes of data more efficiently and productively. However, a crucial precursor to properly and fully utilizing AI, is the meticulous structuring of laboratory data.
This white paper delves into the multi-faceted implications of structured lab data, popular data systems used in today’s lab environment, how to determine and prepare your organization for compatible and successful AI-driven development, how to prepare and find the right AI solution for your organization, and best practices for R&D organizations as a roadmap to guide the way for AI-driven formulation and measurement in R&D.
X-ray Absorption Fine Structure (XAFS) spectroscopy is a powerful materials characterization technique that has historically been underutilized in industrial applications. The reason for this stems largely from XAFS measurements only being available at synchrotron x-ray sources, a model which is ill-suited for routine applications in R&D, quality control, and process monitoring. The recent emergence of high-performing, laboratory-scale XAFS instruments, however, are set to change all of that.
Download this white paper to delve into the recent development of laboratory-based, synchrotron-quality XAFS systems that are revolutionizing the field. These reliable, in-house analytical instruments are rapidly expanding access to XAFS, opening up exciting new possibilities for catalysis, electrical energy storage, heavy element chemistry, mineral extraction, and many other industrial applications.
As the global population continues to grow, traditional farming alone is not sufficient to satisfy the rising food demand. Therefore, the need for sustainable food production becomes more critical than ever. Currently, there are several promising alternative and plant-based food sources derived from insects, cultured meat, fungi, algae, lentils, peas, soybeans, oats, and more.
In our whitepaper, we explore innovative strategies to address the growing need for food while reducing environmental impact. We delve into alternative food sources that excel in flavor, availability, sustainability, cost-effectiveness, and nutrient composition and the key analytical innovations needed to bring them to market.
Everyone wants to live and work in buildings that are sustainable and healthy. However, making common construction materials such as concrete and glass generates carbon emissions, and many paints, adhesives, and plastics are made with fossil fuels.
A growing number of biobased building materials are becoming commercially available, and soy is one of the ingredients at the heart of these innovations. Learn how soy-based products can be used in a variety of environmentally friendly building materials, including roofing materials, concrete, asphalt, paint, plywood, and artificial turf.
Cleaning products need to be sustainable, eco-friendly, and perform well. Traditional ingredients perform well but are not sustainable. A lot of sustainable formulations lack the cleaning power of traditional formulations. Cosun Biobased Experts produces a performance enhancing ingredient that is plant-derived and enhances the performance of both detergents and hard surface cleaners.
Carboxyline® CMI a versatile ingredient derived from inulin, a natural polysaccharide found in plants. Carboxyline® CMI offers a unique combination of anti-scaling, sequestration, and dispersing properties. It is an anionic functionalized biopolymer capable of boosting the performance of detergents and hard surface cleaners.
Studying protein interactions at a subcellular level is essential for advancing life sciences research, understanding the underlying mechanisms of disease, and developing new therapeutics. But many traditional methods for studying these interactions have constraints that prevent researchers from comprehensively connecting interactions to cellular function. Commonly used techniques have limited sensitivity or selectivity, leading to results containing many interactions with lower confidence of being relevant to the intended target.
Now, a new tool for protein proximity labeling maps protein-protein or protein-small molecule interactions within a 4nm radius of a target protein. This ebook explores how micromapping can support discoveries in fundamental biology and pharmaceutical development.
Gene therapies are increasingly in clinical trials and they are predicted to regularly advance to market. These products use viruses or lipid nanoparticles as vectors to deliver genetic material. Their inherent complexity creates challenges for characterization.
Light-scattering analysis—either as a stand-alone method or combined with separation techniques—can quantify attributes associated with safety, efficacy, and potency. These methods rapidly characterize small lot-to-lot variations, which supports quick and thorough product development, process optimization, and quality control.
Download this ebook to learn how light-scattering and size separation methods are poised to help accelerate and safeguard gene therapy programs throughout development and into the clinic.
Oligonucleotide-based therapeutics are set to transform the landscape of treatable human disease. Many traditional pharmacological treatments use small molecules to directly modulate the activity of proteins involved with disease. Yet only about 25% of disease-related proteins have been drugged to date, and the vast space of the human genome provides a variety of biochemical mechanisms to target for treating disease.
Nucleic acid therapies act before protein production, provide instructions for functional proteins, or initiate degradation. While creating oligonucleotide therapeutics is theoretically as straightforward as a sequence of chemical building blocks, designing effective treatments for clinical applications involves understanding both the chemistry and biology of nucleic acids.
The trend towards more complex molecules, materials and systems brings new crystallization challenges for products such as pharmaceuticals. The solution to these challenges lies in a fundamental understanding of solubility - the driving force and crystallization kinetics onto which we can build innovative, integrated, and intensified continuous crystallization processes. Learn about methods for reliably measuring solubility with different solvents and of complex mixtures such as co-crystals. Selecting solvents and mixtures that spans the range of possible chemical functionalities will maximize the chances of finding new, interesting, and developable solid forms in drug discovery.
Personal care companies are under pressure to adapt to changing market demands and evolving customer preferences brought about by the COVID-19 pandemic, supply chain disruptions, increased globalization, and sustainability concerns. One solution is to reformulate their products to meet current market needs — from sustainability to trendy ingredients—while setting themselves apart from competitors.
Reformulation involves overhauling product ingredients to improve a product. It may be a lengthy process, but many companies are gaining benefits.
Per- and polyfluoroalkyl substances (PFAS) have recently gained significant attention as an emerging threat. As a result, the EPA has developed a regulatory strategy to address PFAS contamination in drinking water. To keep up with regulatory requirements, there are analytical challenges that require highly sensitive mass spectrometers or sample preparation techniques, such as solid phase extraction coupled with LC/MS/MS, as implemented in EPA Method 537.1 and 533.
In this whitepaper, discover key insights into United States regulatory requirements and the latest analytical innovations to optimize PFAS analysis, as required by the Environmental Protection Agency (EPA) Methods 533 and 537.1 as well as emerging methods in non-potable water matrices such as Method .
All solid-state battery (ASSB) technology, defined as having only solid components, will unlock materials chemistry limitations from traditional battery technologies and enable alternative activities and advanced designs. The costs of battery manufacturing are trending down, and energy density is trending up, however, this trend is plateauing. This plateau in energy density and cost efficiency offers a perfect opportunity for new battery innovations and ASSBs stand to be the primary battery system of the future.
In this whitepaper, we will look at the factors that need to be overcome by ASSB developers in order to dominant the battery landscape, as well as the newest ASSBs designs, innovations and analytical equipment considerations to support ASSBs' meteoric breakthrough into the battery landscape.
In the last decade, high-resolution mass spectrometry (HRMS) has emerged as a powerful technique in many fields of biological studies, pharmaceutical and nutraceutical research and environmental analysis.
Thanks to the high resolution and accuracy in results, targeted and untargeted analysis and structural information obtained by MS in tandem analysis, the QTOF-MS instrument has been widely exploited for comprehensive drug screening in biological samples.
Olon uses a well-established technological platform to produce peptides via a recombinant approach that involves strain design, construction and improvement, as well as fermentation and downstream process design and optimization for the isolation and purification of peptides as active pharmaceutical ingredients (APIs).
The process, and particularly the purification step, must ensure not only consistent quality through all batches, but also the safety and efficacy of the final product. To this end, this whitepaper shows how a HRMS method can be used to identify and characterize unknown impurities in samples of recombinant peptides.
Chemists have long endeavored to do more with fewer experiments, less material, and in less time across the entirety of the chemical product lifecycle. Companies across the pharmaceutical, agriculture, chemical, and energy sectors are systematically adopting metrics and strategic initiatives to ensure their products and processes are efficient, effective, and safe in ways that are beneficial to both their business and the environment.
Developing products and processes with these goals in mind requires the right tools. Download this whitepaper to learn how advanced real-time analysis, automated synthesis, and artificial intelligence modeling tools can support a strategic drive towards green and sustainable chemistry.
An ion chromatograph is a complex device with many different components, each with its own unique and important function. To ensure the best measurements possible, as well as minimal instrument downtime, it is essential to understand these components and know when items need to be replaced or inspected.
In addition to performing regular maintenance, learning how to independently do basic troubleshooting can save you time and resources in the long run. A combination of carefully reading the data and inspecting system components can often lead you to a simple solution to the problem.
Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract. Most crystalline TKI drugs have pH-dependent solubility that affects their bioavailability in an oral dosage form. Consequently, natural variations in gastric pH, or variations due to eating or taking antacids, can significantly impact drug absorption and, in turn, therapeutic efficacy.
Alternative formulation techniques such as amorphous solid dispersion (ASD) can still deliver the convenience of a pill while reducing TKIs’ sensitivity to physiological variation. This ensures more consistent—and higher—bioavailability. This whitepaper outlines the challenges associated with pH-dependent solubility for oral TKI drugs and reviews how leveraging ASD formulation can help create more effective, patient-friendly drug products.
Most medicines in development today target diseases affecting large sections of the global population. However, we are now slowly beginning to see a rise in interest around developing "orphan drugs," which are pharmaceutical agents intended to treat rare diseases. The global orphan drug market is projected to increase at a compound annual growth rate (CAGR) of 12.10% between and and is expected to achieve a net valuation of US$318.5 billion by the end of .
As more drug developers become interested in sponsoring an orphan drug program, it's important to understand the challenges associated with developing these drugs on an expedited timeline, as well as ways to mitigate these challenges.
Recent helium shortages have become acute in many regions, resulting in price increases, and even stopped shipments. These shortages jeopardize the operations of labs that depend on gas chromatography. Hydrogen (H2) being a low-cost and easy to procure gas is a good alternative to helium. However, owing to its non-inert nature, it causes unwanted reactions in the MS source.
The Agilent HydroInert source addresses this problem and is ideal for labs that are considering hydrogen but are worried about analytical limitations.
HydroInert allows you to:
• Prevent work stoppages caused by insufficient helium supplies
• Reduce sensitivity loss and spectral anomalies
• Achieve faster, shorter separations
• Minimize downtime caused by system maintenance and ion source cleaning
In this collection of app notes, you will learn about resources from Agilent to ease the transition from helium to hydrogen, allowing GC/MS labs uninterrupted operations.
System upgrades keep instruments up to date, provide new features and functionality, and address data security vulnerabilities. But when upgrading frequently used instruments, such as chromatography equipment, practical challenges come with the benefits. Lab managers have to choose an upgrade approach, collaborate with their organization’s IT department, and manage regular lab operations during the transition. Here are answers to 10 common questions about the process of a chromatography data system (CDS) upgrade.
Low doses of highly potent active pharmaceutical ingredients (HPAPIs) treat cancer, autoimmune diseases, and other medical conditions, often with reduced side effects. Because these compounds can have a major cytotoxic effect in even tiny amounts, their safe handling is a challenge for personnel during manufacturing. Drug manufacturers must take precautions at every step of production.
Those safeguards can seem burdensome when flexibility to handle to handle different substances, formulations, batch sizes and production processes is critical to keeping a drug development project on track, on time, and on budget. Partnering with a contract development and manufacturing organization with expertise in safely handling HPAPIs can be a valued asset in the development process.
DNA-encoded library (DEL) screening technology is changing the game of hit identification during early-stage drug discovery—by allowing billions of molecules to be tested against a biological target, at the same time and in a single Eppendorf tube.
With a vastly increased number of compounds tested, the likelihood of finding a hit goes up. But this isn’t just a numbers game; the chemistry matters, particularly molecular weight. DEL technology is also significantly cheaper per molecule screened compared to traditional compound libraries.
Neurodegenerative diseases affect millions of people worldwide and will continue to be a leading cause of disease and disability as the world population ages. Yet effective treatments for these diseases remains an urgent unmet medical need, with limited therapeutics currently available. Challenges during the drug discovery and development process lead to longer development timelines and may exclude smaller innovators from entering the therapeutic space. New approaches are needed to spur innovation and introduce new treatments to the market.
Neurodegenerative disease drug development requires expertise that spans the gamut of pharmacological and preclinical investigations. Regardless of their size, innovators can benefit from partnering with a contract development and manufacturing organization (CDMO) during the drug development process. CDMOs offer new approaches to drug target identification, lead follow-up, and preclinical animal models and read-outs. This whitepaper highlights how thoughtful consideration of a CDMO partner can help companies meet neurodegenerative disease drug discovery head-on to develop the medications of the future.
Micro- and nanocapsules loaded with chemical payloads could provide a powerful tool for a wide range of industrial, medical, and commercial applications. Accordingly, the hunt is on for molecular building blocks that can be employed for the efficient, reproducible, and affordable assembly of such tiny vessels.
Colloidal silica offers a promising solution on this front. This material is a well-characterized, widely-used mainstay of the manufacturing and scientific world, and a number of research groups have demonstrated the feasibility of building colloidal silica-based capsules for the trapping and controlled release of a diverse range of cargos. This whitepaper looks at the current state of the field, the challenges remaining to be overcome, and the applications where colloidal silica encapsulation might prove most powerful.
Philip Wheeler, Business Development Manager at Umicore PMC, explores modern approaches in cross-coupling catalysis technologies and how recent developments are enabling innovative discoveries. Using some of the latest cross-coupling innovations as case studies, this whitepaper showcases how the researchers are overcoming modern hurdles to advance the field and extend the ability of this already versatile chemistry. These exciting new developments are paving the way toward new discoveries and greater optimization across an array of fields, including the production of active pharmaceutical ingredients and the development of ingredients for crop protection.
Gene therapy has been hailed as a revolutionary approach to prevent or treat diseases ranging from inherited disorders to cancer. One way to deliver DNA therapy to a patient’s cells is using viruses that do not cause disease in humans. Adeno-associated viruses (AAVs) are the viral carriers of choice for many gene therapy applications due to their history of low immunogenicity and good clinical outcomes for patients.
AAV are produced commercially in mammalian and insect cells, which means scalable, efficient purification strategies are critical to meeting quality standards and clinical demand. Affinity chromatography resins designed to broadly capture AAVs, or capture AAV subtypes, provide solutions to help manufacturers overcome purification bottlenecks. Affinity resins that capture non-target viruses can also clear contaminants to ensure AAV products meet clinical purity standards. With efficient processes in place, biomanufacturers can ensure that AAV production does not hinder the pace of gene therapy development.
The parasite that causes malaria has no clear biological target for researchers to target with a vaccine. Despite decades of development, only one malaria vaccine to date has been approved by the World Health Organization.
Researchers have a pipeline of malaria vaccine candidates in development and clinical trials. Antigens for each vaccine are manufactured using the same blueprint, which includes using a novel purification approach for a biotherapeutic: affinity chromatography.
Producing each antigen with the same affinity tag has enabled the team to streamline purification, keep costs down, and rapidly advance their vaccine candidates into the clinic.
Predictive modeling has the potential to aid in developing robust drug development and manufacturing platforms. However, realizing the full potential of the technology requires careful selection and application of in silico strategies and a deep understanding of how to interpret and derive the most valuable insights from the data. This report provides a framework for that understanding by outlining some of the processes that stand to gain the most from computational modeling and identifying the in silico capabilities that can be used to accelerate and de-risk each phase of development.
Some of the key modeling capabilities that will be discussed include:
·Predictive modeling for solubility and bioavailability enhancement
·Accelerated stability modeling for shelf life and packaging determination
·Materials science, compaction simulation, and process modeling
·ADME-PK modeling to predict the effect of API physicochemical properties and pharmacokinetics
The steady stream of plastic production and consumption poses one of humanity’s biggest sustainability challenges, filling the seas and soil with waste that will take millennia to degrade. But a new generation of chemists is rising to meet this challenge.
This whitepaper will look at some of the innovative research that can help make future plastic products more environmentally friendly and reusable, and reverse the accumulation of harmful polymer byproducts.
Virus like particles are a powerful platform to generate highly immunogenic vaccines, particularly for viruses that are mutating frequently. These particles are made from viral proteins that self-assemble into a structure resembling a virus’s outer shell. Vaccines based on virus like particles for hepatitis B and human papillomavirus are available commercially.
An integrated system of tools for protein expression, purification, and quality control testing can help support efficient and cost-effective virus like particle production on a commercial scale.
While many plastic products are technically recyclable, more than 90 percent of them are incinerated or deposited into landfills or the natural environment. Stakeholders all along the plastics value chain face pressure to increase the percentage of post-consumer resin (PCR)—pellets or flakes of recycled plastic—in their products. Consistency issues between and within batches of PCR feedstock make this material challenging to process reliably. This whitepaper highlights the current challenges in plastics recycling, describes sources of variability in PCR feedstocks, and explains how two fundamental materials science measurements can provide quantitative information about that variation so that scientists can adjust formulations while using PCR in production.
The COVID-19 pandemic showed the world that when it comes to pharmaceuticals, fast is achievable. Traditional models for drug development, manufacture, approval, and launch were upended. Timelines were shrunk and processes streamlined; existing drugs were repurposed, and the launch of novel ones accelerated. Bold new approaches led to countless lives being saved. Now, drug researchers and developers, manufacturers, and raw material suppliers are applying lessons learned to accelerating the future of pharma. This radical rethink will not only support future pandemic preparedness, but it will also revolutionize how pharmaceuticals targeting other diseases are developed and manufactured.
The cannabis industry is rapidly changing, offering significant opportunity for those companies willing to navigate its regulatory and scientific complexities and uncertainties. While the upsurge in legal supply, consumer demand, and medical research are starting to converge, the growing challenge for the cannabis industry is consistency.
Emerging technology is intended to test cannabis crops in the field for levels of psychoactive tetrahydrocannabinol (THC), levels of which are regulated, and non-psychoactive cannabidiol (CBD), which is extracted and used in consumer products from lotions to edibles. Data from state-certified labs performing quality testing could inform efforts to standardize cannabis-based products. And attention to chemicals used during cannabis manufacturing can establish quality from the field through to a finished product.
Securing the drug supply is a global concern. The pharmaceutical industry is supported by a worldwide web of suppliers and chemical manufacturers. Knowing where raw materials are orginating and how they have been handled is complex, yet critical. From small-molecule drugs to more complex biologics, quality control is the key to a safe and secure drug supply. The US Drug Quality and Security Act was established to provide the FDA and drug manufacturers with guidance for handling drugs safely within this complex and rapidly expanding industry. Download the ebook to learn more about these emerging regulations and how they will impact both small-molecule and biopharmaceutical drug manufacturing.
The steady stream of plastic production and consumption poses one of humanity’s biggest sustainability challenges, filling the seas and soil with waste that will take millennia to degrade. But a new generation of chemists is rising to meet this challenge. This white paper will look at some of the innovative research that can help make future plastic products more environmentally friendly and reusable, and reverse the accumulation of harmful polymer byproducts.
Cellulose nanofibers (CNF) are plant-derived carbon-neutral materials which are light-weight and strong, yet also exhibit high elasticity and resistance to heat. The main component of CNF, cellulose, can be biosynthesized in large quantities through photosynthesis and it is abundantly available in nature. Shimadzu provides solutions for detailed analysis of CNF properties. In this booklet, these analyses are further explored comprehensively to help you better investigate and characterize nanocellulose materials.
As the world moves towards increased automation, electronic record-keeping, and cloud connectivity, there is also significant innovation in communication tools. For chemists, these innovations bring about revolutionary changes in how they share their research.
Learn how innovative software can empower today’s chemists to search, reuse, and report their ChemDraw data efficiently and seamlessly. This whitepaper delves into the current communication struggles in chemistry research and how they can be easily overcome with purpose-built, innovative software.
All labs face common challenges, including new ones posed by COVID-19. But, unlike our personal lives, most labs aren’t thoroughly digitalized. This makes those challenges—manual data capture, chemical handling, disposal of unused expired chemicals, real-time access to materials data from anywhere—harder to meet. What if we could create inventory efficiencies by slashing time spent on admin, boost data traceability by digitally ensuring materials/data integrity, and digitize paper trails by harmonizing user access to real-time information? We could indeed, using the LANEXO® Laboratory Inventory, Safety and Compliance Management System.
The application of Process Analytical Technology (PAT) methods is of ever-increasing importance in all areas of academic and industrial synthetic chemistry. Real-time reaction analysis is a major element in an overall PAT strategy, which includes advanced analytics, modeling and digitalization. The overall goal of a PAT strategy is to acquire and transform data into actionable information that speeds reaction understanding and process knowledge to maximize yield, quality and sustainability of chemical syntheses.
Dependent on the specific chemistry, spectroscopic methods including FTIR, Raman, UV/Vis, NIR, NMR and MS can be chosen to enable real-time analysis. State-of-the-art chromatographic methods such as UPLC are also available for online reaction analysis. These technologies provide extensive data streams that can be analyzed with advanced analysis and modeling tools. Frequently, multiple real-time analysis techniques are used in combination to provide data that fully characterize a reaction or process.
The current generation of solid core particles for LC analysis were introduced in and provide higher efficiency separations than equivalently sized fully porous particles. Since then, their use for the analysis of both small and large molecules has increased steadily, in a wide variety of analytical fields, to drive high performance separations and increases in laboratory throughput. This white paper focusses on the application of solid core particles to small molecule analysis. It begins by introducing the concept of solid core particles, their morphology, history of development and current methods of synthesis, before moving on to discuss the theory behind the performance advantages they offer. Finally, example applications that demonstrate how these particles can be used to provide solutions for some of the analytical challenges faced by the modern chromatography laboratory are discussed.
High pressure liquid chromatography (HPLC) is a benchmark technique used in laboratories across the world. However, even experienced analysts that are familiar with HPLC concepts and principles can fall victim to chromatographic pitfalls that arise. Some common issues include misshapen peaks, unstable baselines, problems with reproducibility,and the observance of irregular back pressure. Identifying and correcting these problems quickly can not only save time but increase productivity in the lab. Chromatographic issues can arise from any part of the system, including the pump, autosampler, column oven, or detector, and each component of the system must be considered individually.
Formulation of effervescent tablets can be tricky due to poor compressibility and segregation tendencies that come from different particle sizes of the components. Self-sustaining effervescent reaction is very sensitive to moisture that creates an additional challenge for product manufacturing and shelf life.
CITROCOAT® EP as an agglomerated compound has an edge over the use of separate components for tableting providing higher reactivity, better storage stability, compactibility and less granular convection. As an example, we are sharing a formulation of Multipurpose Cleaner tab where we were able to achieve the target tablet hardness with reduced compression force and improved tablet storage stability.
Readers can expect to learn about the development of a more natural chewing gum using ERYLITE® instead of xylitol. In this paper, we discuss various strategies on the development of a chewing gum using not only ERYLITE®, but even the gum base as well. We evaluate different samples for storage stability, texture, and other sensory traits.
Innovations in drug development, including an enhanced focus on targeted therapeutics and advanced screening methods, have led to an increase in the number of highly potent APIs (HPAPIs); in turn, this can deliver drugs requiring lower doses with fewer side effects. But safely working with these compounds during development and manufacturing can be a challenge, requiring stringent processes and specialized, qualified equipment to ensure containment, provide operator safety, and minimize risk of cross-contamination. The facilities working with HPAPIs need to have robust capabilities in chemical synthesis, purification, and analysis to properly support these drug product programs.
Computer-aided drug design (CADD) techniques are a routine part of modern drug development. Modeling before laboratory experiments maximizes the potential to discover a molecule with the best therapeutic potential among the vast number of possibilities. However, classical mechanical and quantum mechanical calculations of 3D shape and electronic structure are often too slow to be applied at a large scale. Adding machine learning to CADD workflows extends their capability to potentially operate at the scale of billions of molecules. The combination of CADD and machine learning could one day speed resource-intensive free energy perturbation (FEP) calculations that predict binding affinity with accuracy comparable to experimental measurements.
Access to published chemical content is essential to the research and development process. In the era of big data, the breadth of available chemical content is vast and steadily expanding. Chemists may find themselves spending more time trying to track down and gain access to the content they need. Once they have it, understanding copyright laws and safe sharing practices are also essential for team collaboration.
Digital tools can help overcome these challenges and streamline how chemists access, manage, and share the content they need. Integrated software that incorporates search engine and document delivery features will expand the information resources chemists have access to. Built-in features that also address copyright compliance will further ensure information is being shared between team members in a safe manner. This whitepaper from Copyright Clearance Center covers how digital information tools help chemists efficiently navigate the literature landscape, freeing up time for researchers to focus on the planning and experimentation that drive innovation.
Continuous chromatography (MCSGP) technology represents great progress in the downstream processing for peptide and oligonucleotide manufacturing. Compared to single-column batch purification, solvent consumption is typically decreased by more than 30% using MCSGP, thus contributing to higher sustainability. Furthermore, this innovative technology leads to an attractive economic benefit due to its automated way of manufacturing. In regular batch purifications, achieving the API’s target purity and impurity profile often comes with a decrease of yield and productivity. In contrast, MCSGP runs 24/7 providing high product yield without adverse impact on purity and impurity profile. Savings in cycle time can reach up to 70%, depending on the compared batch chromatography.
This application compendium contains a collection of environmental and food testing application notes demonstrating the low detection levels and sensitivity of the Agilent Triple Quadrupole GC/MS systems for the quantitation of pesticides, volatile and semi volatile compounds to include:
-Estimation of Ethylene Oxide and Ethylene Chlorohydrin in Sesame Seeds Usingn Agilent GC and D Triple Quadrupole MS System
-Low Calibration Limit Research for Multiresidue Pesticides in Milk Using the Agilent /B and B/C Triple Quadrupole GC/MS Systems
-Use of Salt to Increase Analyte Concentration in SPME Headspace Applications
-Analysis of Free Volatile Phenols in Smoke-Impacted Wines by SPME
-Analysis of 1,4-dioxane in Water by Purge and Trap
In modern production of small molecule pharmaceuticals and biopharmaceuticals, the reaction must be closely monitored and potentially even controlled by online reaction monitoring analytics.
This application note demonstrates the use of the Agilent InfinityLab Online LC Solution for monitoring reactions with different reaction speeds. The method requires high sampling speeds for sampling and quenching, as well as direct injection for the fastest results. As a model reaction, the pH-dependent hydrolysis of acetylsalicylic acid (Aspirin) to salicylic acid has been used.
Lipid nanoparticles (LNPs) have emerged as promising delivery vehicles for nucleic acids in the pharmaceutical industry. To ensure safety and efficacy of the final drug product, the lipid components need analytical characterization of composition, ratio, and degradation.
The Agilent Infinity II Bio LC enables you to do just that. Download this application demonstrating the analysis of the lipid components of patisaran (trade name Onpattro). Optimal separation of the four LNP components with excellent peak shapes, precision, and sensitivity was achieved.
Active pharmaceutical ingredients, or APIs, are what make a drug a drug - they produce the desired effect. The process of formulation converts APIs into drug products that patients can use. Most marketed pharmaceutical drugs are manufactured in solid forms such as tablets, capsules, and powders. Now the long-standing, well standardized practice of formulation is facing new challenges. Some advanced APIs are not compatible with standard approaches to formulation due to issues with stability, solubility, or other physicochemical characteristics. In this whitepaper, you will learn about innovative new approaches to solid dosage formulation and how partnering with a contract development and manufacturing organization, or CDMO, that specializes in these techniques will benefit your drug development pipeline.
Pressure reactors are prized in the pharmaceutical and petrochemical industries for their ability to speed up slow reactions, such as hydrogenations. When choosing a pressure reactor, scientists must weigh many factors related to the type and scale of the desired reaction. This white paper will walk readers through the various design features of pressure reactors, giving them the tools to make an informed decision that will improve the safety and efficiency of their laboratory.
Every drug begins its journey to the clinic with preclinical testing to help predict whether the compound will work and if there is any risk to the patient. One required aspect of this risk assessment is to look for potential drug-drug interactions (DDI). This ebook will explore the regulatory expectations of drug developers to research DDI potential, the relationship between a drug’s characteristics and DDI risk, the methods available to test those characteristics, and considerations for drug developers to plan and successfully navigate DDI risk assessment.
The application of pesticides is an important aspect of crop protection, and enhancing their efficacy is a key strategy to maximizing their benefits. One way to do this is through the use of spray adjuvants. These compounds act on the spray droplets themselves, influencing properties such as drift, wettability, or spreadability. Many of these adjuvants are synthetic in nature or petrochemical-based.
Xanthan gum and CITROFOL® AI (triethyl citrate) constitute a promising alternative to synthetic adjuvants. In this white paper, we will explore how these compounds can enhance spray performance while meeting the demand for more bio-based and biodegradable options.
Peptides have emerged as valuable therapeutics due to their attractive drug properties and are being developed to treat ailments ranging from cancer to diabetes. With many new therapeutic peptides in the development pipeline, the peptide market is expected to continue to expand in upcoming years. However, the full potential of this class of therapeutics has yet to be realized due to challenges associated with their development and production.
Partnering with specialists including contract development and manufacturing organizations (CDMOs) can help innovators overcome hurdles associated with therapeutic peptide development and production. CDMOs possess the capability, capacity, and expertise to help partners achieve the output they need to move their peptides through the research and clinical trial stages and, ultimately, to market. This white paper from WuXi STA highlights the versatile services and capabilities a CDMO can provide as a partner during peptide development and manufacturing.
Gene therapy and gene editing are expected to revolutionize life for an increasing number of rare-disease patients in the coming years. The adeno-associated viruses (AAVs) are being used as delivery vehicles by many pharmaceutical and biotechnology companies for the delivery of replacement genes and gene editing tools inside patients’ bodies. To date, three AAV therapies have achieved marketing approval and these viruses have also been used in almost 300 clinical trials.
However, AAVs aren’t currently the perfect delivery vehicles in every situation and research efforts are ongoing to address challenges associated with their small size, efficacy, and safety concerns.
Cells in the human body are equipped with various systems for producing and disposing of proteins. These include transcriptional and translational machinery, through which proteins are expressed, as well as the ubiquitin-proteasome system, which identifies, labels, and destroys unused or damaged proteins.
This whitepaper reviews two novel mechanisms in drug development, both of which harness the innate processes of the cell to modulate protein levels for therapeutic benefit. Armed with new insights into how these systems work, scientists have worked to design drug molecules that will harness these systems to treat or cure diseases of protein deficiency and/or overactivity. Nucleic acid therapies have the potential to circumvent defective genes and produce needed proteins. Meanwhile, targeted protein degradation offers a way to remove harmful proteins from the cell.
Colloidal silica is a mainstay for everyday applications such as papermaking, polishing the silicon wafers used to make computer microchips, making nonslip and abrasion-resistant coatings, and soaking up unwanted moisture. But colloidal silica can also stabilize the ground under buildings during earthquakes and stop the spread of toxic pollutants below ground. This versatile nanomaterial not only preserves ancient carvings in the jungle but keeps the lenses and sensors aboard space vehicles clear and clean, and it stands up to the hot, salty environment of petroleum and natural gas wells.
The chemicals in nearly every modern manufactured item can be traced back to an oil or natural gas well. But that is changing. In the search for more renewable and sustainable sources of chemicals, soybeans are emerging as a versatile and abundant chemical feedstock. Already, soybean-derived adhesives and plastics are showing up in products as diverse as kitchen cabinets and artificial turfs. Download the ebook to learn how soybeans are replacing petrochemicals in everyday products.
Poor bioavailability and solubility are leading causes of drug development failure. This white paper delves into current technological innovations in nanoparticle engineering that aim to increase the number of drugs reaching the market by improving these properties. In particular, Nanoform’s Controlled Expansion of Supercritical Solutions (CESS®) nanoparticle engineering technology is explored as a technique that can uniformly shrink down the size of API particles in a sustainable and controlled process.
The white paper goes on to discuss the potential advantages the technology could bring to patients at all stages of life, including by facilitating novel drug delivery routes, increasing the number of drugs that succeed in clinical trials and reducing both dosage and side effects. Additionally, this white paper features a Nanoform case study on the use of CESS® to enhance the pharmacokinetic properties of piroxicam, a popular anti-inflammatory drug, and concludes with a focus on future expectations for the technology in the field.
Synthetic chemists rely heavily on a small number of transformation types when planning synthetic routes. The knock-on effect is that they have only explored a few pockets of chemical space. New catalytic innovations will enable them to search further than ever before.
These catalysts may lead to areas of chemical space populated with molecules that can be used as universal cures for cancer, ones that can stop a pandemic in its tracks, or a high-performance polymer that somehow knows to decompose immediately after use.
This paper looks at examples of curing systems through Differential Scanning Calorimetry (DSC) experiments across an array of applications and testing purposes. In all cases, new technology offers the opportunity for improved results in less time.
Curing materials (e.g. thermosets, rubbers) must be thoroughly tested to ensure their quality and reliability. Analysis usually requires DSC instruments to study cure exotherms, glass transitions, and other thermal properties. New DSC technology is drastically improving curing analysis techniques and setting a new standard for accuracy and efficiency. From material development and failure analysis to product quality control, all aspects of cure analysis are evolving. Improved cure testing equates to improved product discovery, safety, and efficacy.
The supply chain. It has morphed from a mere cost center to mission critical in business discussions. The chemical supply chain is especially getting its time under the spotlight because it can make or break a whole range of industries. Biotechnology, pharmaceuticals, cosmetics, paper production and recycling, nutrition and more all feed on chemicals.
The COVID-19 pandemic has exposed key vulnerabilities in the supply chain that the chemical industry is learning from and setting into motion. Dive into what went wrong during the pandemic and five key lessons that will mold the future of the chemical supply chain.
Determining measurement uncertainty during weighing is something scientists in multiple industries must grapple with. The routes to calculating these values range from highly precise calculations to educated guesses. There is now an alternative: a software function for determining measurement uncertainty.
Regardless of how measurement uncertainty is calculated, there is a lot balance users can do during the weighing process to limit uncertainties in their results. This whitepaper highlights the top 8 uncertainty contributors to watch out for.
Vaccines are critical for disease protection. Rapid vaccine development will be important to respond to new and emerging diseases, as demonstrated by the COVID-19 pandemic caused by SARS-CoV-2. In the past decade, new vaccine types have been developed and can be adapted for use against numerous diseases. However, each type comes with its own manufacturing challenges. Developing versatile purification and quality control methods can help overcome these challenges and meet global demand for vaccines of all types.
Affinity and non-affinity chromatography resins are critical to achieving the high purity and yield needed to produce effective and ample vaccines. Affinity resins developed based on the variable antigen-binding region (VHH) of camelid heavy-chain only antibodies can improve selectivity in vaccine purification protocols. Having a varied suite of non-affinity resins can further improve purity and yield. Furthermore, the development of rapid and accurate quality control assessments can ensure vaccine components are sufficiently pure throughout the manufacturing process, thus improving process design. This whitepaper from Thermo Fisher Scientific highlights how the combination of versatile chromatography resins and quality control assessments can accelerate vaccine manufacturing processes.
The chemical industry relies on innovation to drive growth and change. Yet recent market trends coupled with advancements in technology and rapidly evolving customer demands have prompted chemical companies to re-think their approach to product development and call for creative solutions. Digital tools are one solution to getting the most out of the current technological moment and spurring innovation of chemical products.
Over the past decade, digital tools have evolved to become more useful and accessible to the chemical industry. Cloud-based electronic lab notebooks and data analysis software, among others, can help chemists seamlessly collaborate and get the most out of their data. This eBook from PerkinElmer describes how digital transformation – the adoption and integration of digital tools across an organization’s operation – can push the chemical industry into the future, helping to ensure that companies can meet world chemical needs today and in the years to come.
here are many improvements to be made to chemical drawing and the way chemists communicate with one another. ChemDraw’s innovative capabilities help chemists work more efficiently, communicate their research more clearly, and reach crucial information faster.
Uncover hidden gems that have been part of ChemDraw for a long time and learn about new tips that will empower you to draw more efficiently, communicate your research visually, and expedite mundane tasks such as managing molecules and reactions as well as everyday reporting.
Laboratories today generate more information than ever before. Nearly all instruments output information digitally, giving researchers the opportunity to quickly analyze and interpret their results. C&EN surveyed readers on behalf of MilliporeSigma to learn how professionals manage and utilize lab data. The survey reveals that the promise of the big data era threatens to be hampered by siloed information, incompatible formats, and limited accessibility. These issues highlight the need for digital laboratory data systems that are versatile enough to incorporate information from disparate sources, allow users across an organization access to that information, and that use universal standards.
For many companies, chemical inventory management is a way to ensure a safe environment for employees as well as for the neighboring community—while never being short of a needed reagent. C&EN BrandLab surveyed readers on behalf of Merck/MilliporeSigma to learn how professionals manage chemical inventory and comply with regulations. Across industries and occupations, a vast majority felt that their biggest problem was that they lacked real-time information and automatic updates on the status and location of chemicals they needed. This lack of information led to decreased productivity and increased waste. These issues highlight the importance of chemical inventory management systems that are accurate, robust, and easy to use.
Silica hydride-based columns have a silica hydride monolayer applied to silica particles. This changes the surface polarity of the stationary phase and also enables the attachment of unique ligands to the surface. Ligands are attached to silica hydride particls using a silicon–carbon bond, which is more robust than the siloxane linkage used for traditional silica particles. This leads to robust, long-lasting columns with unusual separation capabilities. Silica hydride columns are suitable for reversed phase, normal phase, and aqueous normal phase chromatography. The latter is a mode unique to silica hydride particles and one that is particularly well suited to the separation of polar compounds.
The detection and quantification of nitrosamine impurities in pharmaceutical materials has become a topic of global concern in recent years. Nitrosamine analysis is challenging and requires the application of highly selective and sensitive analytical techniques, capable of quantification in the low ppb range. This white paper discusses how LC-MS/MS methods can be developed and applied to the determination of a range of nitrosamine impurities, highlighted by regulatory authorities, in pharmaceutical APIs.
Additionally, the impact of isobaric interference from N,N-dimethylformamide (DMF), which may co-elute with and result in over-quantification of NDMA, is assessed. Varying the LC stationary phase chemistry to improve chromatographic retention and resolution of NDMA and DMF, along with considered selection of appropriate MRM transitions, was found to provide a solution to improve NDMA quantification accuracy.
Customers often ask how to decide which column size (length, ID, particle size) to use or which size to purchase for a new method development project. Such a decision can be made easier if you think about what you’d like to accomplish, and if you have some ways of making that decision more accurately, so that you ensure you will be successful. In this white paper, we will discuss some useful calculations that will help you choose a column that will be fit for your desired purpose.
Post-translational modifications (PTMs) occur for proteins intended for both intracellular and extracellular functions. These biochemical changes to a protein can be enzymatic or non-enzymatic and may involve changes to amino acids' side-chain functional groups and their N-termini, as well as peptide hydrolysis. Many PTMs are polar by their nature, including glycosylation, deamidation, and oxidation.
These types of polar modifications are more readily analyzed (as released species or as modified proteins) using hydrophilic interaction liquid chromatography (HILIC) because they are retained and resolved better compared to reversed-phase liquid chromatography (RPLC).
In this white paper we investigate the characterization of glycosylation, deamidation, and oxidation as different types of PTMs
Zinc has been gathering attention in recent years as a key ingredient in health-focused formulations as it supports normal function of the immune system. Multiple forms of zinc are approved for use in food and dietary supplements, but many of them have drawbacks regarding taste and bioavailability. This paper presents zinc citrate as a great solution for formulation and supplementation due to its high bioavailability, high zinc content (31%), and preferred sensory properties.
If you want to learn more, please visit our website Lianhe Aigen.
Demand is increasing for efficient, sustainable, and less hazardous active ingredients in surface and skin disinfectants. L(+)-lactic acid is one of a few fully bio-based, proven active substances. It is the ideal ingredient to improve the green profile of cleaning products without compromising on efficacy. While much is already known about the bactericidal properties of L(+)-lactic acid, this paper will demonstrate its effectiveness against enveloped viruses.
Pharmaceutical companies and researchers pour years of effort and billions of dollars into drug design and development. At every phase of drug discovery, see how artificial intelligence is accelerating workflows to cut costs, save time, and enable new drugs going to market faster than ever before.
Learn about how AI is enhancing protein structure determination, chemoinformatics, molecular simulations, and more in this industry brief.
Chelating agents are used in industrial fields, where the presence of metal ions might negatively impact the application. By sequestering metal ions, chelating agents prevent them from interfering with a products performance. In home care applications, chelating agents improve the effectiveness of surfactants by hindering the formation of insoluble salts.
This white paper describes the process for appropriate use of citrates and gluconates as chelating agents in home care formulations
Biotherapeutics have a successful record for treating diseases and account for almost half of new drug approvals in the U.S. These therapeutics are produced in biological systems and thus present unique manufacturing challenges to achieve the yield and purity needed for an efficacious and safe treatment. Affinity ligands, which are designed to target a specific molecule, are commonly used during the biotherapeutic manufacturing pipeline to both capture and analyze the target molecule.
In recent years, biotherapeutic versatility has expanded. Manufacturing and analytical processes need to be tailored to each individual biotherapeutic, which can be challenging because not all molecules have established or commercially available chromatography resins. Development of affinity chromatography resins, including those based on the variable antigen-binding region (VHH) of camelid heavy-chain only antibodies, have helped improve protocols for biotherapeutic development and manufacturing. This whitepaper from Thermo Fisher Scientific highlights the versatility of these affinity ligands and explores how they can support the development of diverse biotherapeutics.
Surprisingly sophisticated chemical coating technology is all around us – even down to the humble potato chip packet. Despite being destined to be thrown into the trash at the end of the snack, potato chip packaging incorporates multiple layers of coating that ensure the packaging retains its bright and vibrant look, while preserving the look, taste, aroma and crunch of the product inside. Colloidal silica is a highly versatile material that can enhance the properties of many coatings – including those used for chip packaging. From improving ink absorption, to enhancing oxygen barrier properties, to making manufacturing easier, colloidal silica coatings have much to offer, in food packaging beyond.
Biotherapeutics can be used to treat numerous diseases and made headlines in the midst of the COVID-19 pandemic as a potentially life-saving treatment against SARS-CoV-2 infection. Market analysis suggests that global demand for biotherapeutic products will continue to increase at a rate that exceeds companies’ current manufacturing capabilities. Because biotherapeutics are produced in complex biological systems, efficient purification strategies are critical to overcoming manufacturing limitations and meeting the needs of patients.
The development of versatile affinity and non-affinity resins is important to improving biotherapeutic manufacturing. Affinity chromatography resins based on the variable antigen-binding region (VHH) of camelid heavy-chain only antibodies can provide high selective affinity for a broad range of biotherapeutic targets, thus improving purification protocols. Likewise, varied non-affinity resins can further improve biotherapeutic purification and yield. This whitepaper from Thermo Fisher Scientific highlights the versatility of affinity and non-affinity resins and explores how they can support purification of diverse biotherapeutics.
Whether teaching a class for the first time or the 51st time, we could all benefit from the insights of our fellow chemistry instructors. Only those who currently work as educators truly understand the complexities facing instructors both in and out of the classroom. As such, we could always use practical and contextual examples from our colleagues in the field.
This guide collects stories and advice from instructors across the country. It highlights chemistry course planning strategies that improve student engagement and learning outcomes, reduce costs for all, save instructors’ time, and ensure easy transitions to hybrid/remote learning.
This paper includes a brief introduction to light scattering (LS) instruments and techniques, and how they are coupled with fractionation techniques. For several classes of vaccines – including subunit vaccines, mRNA-LNPs, polysaccharide conjugates, and plain old viruses – case studies demonstrate the utility and breadth of analyses using the light scattering toolkit.
These include measuring size distributions, characterizing protein-protein binding, and quantifying glycan content in glycoproteins or nucleic acid cargo in nanocarriers. Multiple ways to detect aggregation and other measures of stability are also described.
Atomic Force Microscopy is a powerful technique for analyzing materials at the nanoscale. Through a variety of different modes, AFM can analyze a wide range of chemical, mechanical and even electrical properties across an extensive variety of materials. This whitepaper reviews the many ways that materials scientists can use AFM to examine polymers’ structure and properties at the microscopic level for a more complete understanding of the material.
Originally developed with a focus on life science, microplate readers have increasingly found their way into chemical applications. Due to the great advantages they offer in terms of time, reagent and ultimately cost savings, they have become an indispensable tool for analytical and testing applications, thereby covering the whole range of chemical research.
In this white paper, we highlight what you have to consider when looking for a microplate reader for chemical applications. Moreover, we discuss case study applications in chemical research from analysis and optimization of compound synthesis, to compound solubility and efficacy tests.
High-potency drugs derived from natural products command a large and growing market share in the pharmaceutical industry.The rich diversity of potent natural products necessitates a range of manufacturing demands. Because HPAPIs are so potent, requiring very little substance to elicit sufficient effect, it is critical to protect employees working with them, as well as the environment. The investment in hardware and expertise to contain these products and measure the effectiveness of that containment is a substantial barrier to entry.
An overview of the tools available to speed up and enhance the organic chemistry workflow from synthesis to isolation. Microwave-assisted synthesis can make some organic reactions faster and more efficient. The basic theory of microwave-assisted synthesis and two examples are described. The next steps after synthesis is separation and isolation. The use of supported ligands for catalyst removal and high performance flash chromatography is described.
At the height of the first wave of the COVID-19 pandemic, consumers around the world experienced a supply shortage related to alcohol-based hand sanitizer. As new producers entered the market, and existing manufacturers sought to ramp-up production to meet the growing demand, lower grades of ethanol and isopropanol (IPA) started to appear on the market. To ensure the safety and efficacy of hand sanitizer products, it is recommended that manufacturers test their products to ensure appropriate levels of active ingredients, as well as a means of ensuring label-claim accuracy. In this application note, an efficient and simple, “dilute and shoot” method for the analysis of IPA and ethanol in hand sanitizer products is detailed. With a run-time of only 5.36 minutes per sample, this method is ideal for operations requiring fast turnaround times that won’t disrupt the production of their products.
In this presentation, we will discuss a new, completely redesigned high-resolution time-of-flight mass spectrometer for GC-MS analysis that combines a new TOF analyzer with integrated software that makes use of all of the available information to identify compounds in complex mixtures. Specifically, this new GC-MS system features increased resolving power (R > 30,000) and high mass accuracy (< 1 ppm) while also offering a full complement of ionization techniques. These include classical electron ionization (EI), three kinds of soft Ionization (CI, PI, FI) and combination EI/FI/FD and EI/PI ion sources. Additionally, the system is equipped with new data analysis software that uses high resolution MS in combination with EI and soft ionization methods to automatically identify analytes within complex mixtures..
Today’s chromatographers face the same challenges that chromatographers faced 25years ago—to develop methods that maximize resolution between their analytes of interest. Selection of an appropriate pH for the analytes of interest is critical for ionizable compounds. Once the stationary phase, organic solvent, and pH are selected, vary temperature and gradient time. Then use of a commercially available method optimization software package is recommended. While C18 is a good all-purpose phase for initial method development, the other phases offer alternate selectivities. It is good practice to screen multiple phases to ensure the best possible separation.
Of all enterprise cheminformatics applications, electronic lab notebooks (ELN) place the most stringent demands on embedded chemical editors. ELNs not only exercise the editor as a chemical query tool, but also require authoring complex reaction schemes, performing stoichiometry calculations, generating chemical properties, and even automating the authoring of synthetic preparation narratives from the chemical reaction drawing.
Learn all the benefits you will derive when ChemDraw, with its 35 year track record of continuous innovation in chemical communications, is enhanced by being embedded in the PerkinElmer Signals™Notebook.
ChemDraw has been the world’s preferred chemistry communication tool since its inception in . Just about everyone in the scientific community has come across ChemDraw. Or, has used it in their labs at some point.
ChemDraw provides time-saving chemical intelligence, publication-worthy graphical templates, and scientific tools. We frequently hear, “I’ve been using ChemDraw for years. I already know how to use it”. But do you?
Download our white paper to learn the latest user-acclaimed tips that will dramatically increase your productivity by saving you valuable time.
Whether you’re an experienced chemist or an aspiring one, ChemDraw allows you to draw organic chemistry without having to master drawing.
Just a few of the important tips you will learn include:
Retrosynthesis planning is a key step for developing novel therapeutics and ensuring sufficient supply of existing treatments, both of which are critical as researchers face and respond to unprecedented diseases. The retrosynthetic process of tracing the synthesis pathway from a desired product back to available building blocks can be time-consuming and tedious. Computational power can aid retrosynthesis design but until recently, has relied on chemical reactions already published in the literature.
SynthiaTM retrosynthesis software, developed by MilliporeSigma, uses hand-coded chemical reaction rules as its knowledge base to provide retrosynthetic pathways independent of the published literature. This rules-based system of artificial intelligence helps researchers quickly assess retrosynthetic routes for a given molecule. This allows researchers to identify compounds that are feasible to synthesize or identify alternate synthesis routes for a desired product, both of which are critical to meet the demand for sufficient supply of existing and novel therapeutics.
The success or failure of many mass spectrometry experiments depends on the ability to reliably detect low-abundance peptides of interest while screening out unwanted noise. High-field asymmetric waveform ion mobility spectrometry (FAIMS) can help users achieve superior selectivity by diverting targeted ions into the MS instrument for analysis, while deflecting away non-target ions that would otherwise generate background interference. This ebook introduces readers to the Thermo Scientific™ FAIMS Pro™ interface, and explores how various research groups in both academia and industry are making use of this technology in their proteomics work. For example, FAIMS can improve limits of detection in assays designed to detect signature of infection or cancer-related biomarkers, or enable superior quantitation in multiplexed MS experiments performed with isobaric labeling techniques. FAIMS Pro offers a simple and user-friendly means for introducing this powerful additional separation step into proteomics experimental workflows, and we hope that these case studies will inspire even more creative applications of this technique in the MS user community.
Transportation is integral to the American way of life. However, the automotive industry is tied with the petrochemical industry, which has raised issues with environmental safety, climate change, and sustainability.
To address the issues of the environment, climate change, and sustainability in the automotive industry, researchers have been developing industrial and commercial products from soybean oil. Many of the most exciting uses of the soy relate to products that can make cars and the driving experience itself more sustainable and environmentally friendly.
Digital transformation has become a hot topic, with increasing demand for it in the chemical industry. Digital technologies have impacted companies for the last two decades in ways that we did not predict. From manufacturing to electronics, the impact has been widespread. A few industries have been hesitant to adopt digital technologies. Among the few industries lagging in digital adoption is the chemicals industry. This is often cited by the lack of tools or measurable impact in conjunction to the risk for chemical companies. However, overcoming these hurdles can help chemical companies reap the benefits of digital transformation.
Until recently, the fate of biobased plastics seemed intertwined with petroleum. Interest in them rose and fell with oil prices. Now, even with the precipitous drop in oil prices due to the COVID-19 pandemic, environmentally conscious consumers’ demand for sustainability, coupled with strict state and federal regulations and bans on non-biodegradable and non-compostable single-use plastics, have pushed agriculturally-derived materials to the forefront.
Plastics made from soy feedstocks hold many advantages for consumers. Soy is a renewable agricultural resource that sequesters atmospheric carbon. Bioplastics from soy, unlike traditional, petroleum plastics, can be synthesized to be industrially compostable or biodegradable. This whitepaper explores the many ways that soy can be used to create environmentally-friendly plastics.
Surfactants made from natural, renewable sources, such as like plant-based oils, have less environmental impact than ones made from nonrenewable sources. Scientists are seeking new applications for surfactants derived from natural sources — soy in particular — with potential applications in personal care products, laundry detergents, and environmental bioremediation.
As ballooning consumer interest in cleaning products sourced from renewable resources dovetails with public efforts to limit toxic environmental contamination, surfactants made from high oleic soybean oil seem poised to reshape the market.
As the SARS-CoV-2 crisis maintains its grip on the world, the pressure to develop and distribute effective treatments and vaccines continues to mount. To spare as many people as possible from this deadly disease, treatments and vaccines that are developed for human use will need to be produced and distributed in massive quantities. So far, there is no approved treatments or vaccines available worldwide. To meet the worldwide demand, drug companies will have to scale up their manufacturing capabilities dramatically. In this planning, buffers must be taken into account. These solutions are indispensable for drug development and manufacturing processes and outsourcing can be essential to increasing manufacturing capacity and speed.
This whitepaper from Thermo Fisher Scientific explores the decisions and economics behind outsourcing buffer preparation.
A new vaccine technology based on mRNA is being tested in human clinical trials, accelerated by the COVID-19 global pandemic. mRNA-based therapeutics for a range of other conditions, from cystic fibrosis to cancer, are also entering early stage clinical trials. As mRNA production rapidly scales up, the critical need for a highly scalable mRNA purification technology has also emerged.
Thermo Fisher’s POROS™ Oligo (dT)25 affinity resin is tailor made for scalable mRNA purification. The mRNA sticks to the resin and impurities are washed away. This whitepaper examines the need for highly scalable mRNA production, and then explores the affinity resin’s advantages over other mRNA purification techniques.
Biopharmaceuticals, a subset of drugs that are manufactured in living cells, have uniquely challenging supply chains due to their large number of raw materials, very high purity requirements, and special packaging considerations. Manufacturers of biopharmaceuticals can tackle these problems more efficiently if they partner with an experienced and qualified supplier. In this whitepaper we address the topics companies should keep in mind when choosing a supply chain partner, including the testing, purification, and packaging services that suppliers can offer.
With the worldwide concern about the ubiquitous presence of pollution and unhealthy levels of chemicals in the environment, the urgent need for monitoring and measuring these in multiple matrices is undeniable. For its part, the EPA has developed, validated and published several LC methods for PFAS and PAH analysis. PFAS analysis can be a challenge for chemists because there are PFAS compounds present in LC systems which can interfere with accurate quantitation, especially at low ppt levels. To combat this, a delay column is recommended to prevent PFAS contamination from coeluting with analyzed samples. Improvements in environmental separations are enabled by utilizing Fused-Core® columns.
When scientists are interested in the elemental and isotopic composition of particulate matter in natural waters or in the air, they use a glass or quartz fiber filter to collect this particulate matter. Subsequently, the filter is combusted using a CHNS elemental analyzer. Filter samples are distinct from other samples commonly analyzed by elemental analyzers. They are very voluminous (especially 47 mm filters) and produce a lot of ash. Oftentimes, the filters are loaded with sample material containing only very low elemental concentrations, making the removal of the ambient air blank very important. Taking these considerations into account, Elementar offers a modified version of its newest CHNS+O+Cl elemental analyzer - the UNICUBE, which is optimized for the analysis of particulate matter on glass fiber filters. This analyzer is already being used by many oceanographers, with some even performing shipboard measurements!
Small molecule drug substance development is often completed without consideration for the final drug product formulation. To some extent this is necessary, as drug substance must be generated before any product development activities can commence. However, both activities are intimately linked by the final purification and isolation step of the chemical synthesis and manufacturing process.
Read this whitepaper to discover why an alternative, integrated approach to formulation should be considered based on the impact of certain API properties on the final drug product.
This White Paper reviews opportunities to accelerate development workflow, optimize purity and yield, and reduce capital investment through the application of modular concepts for the continuous manufacturing of APIs or advanced intermediates under cGMP conditions. A new modular continuous plant (MCP) with sufficient design versatility to facilitate rapid, cost-effective manufacturing under cGMP conditions is discussed. As a case study, the development of continuous manufacturing process utilizing Continued Stirred Tank Reactors (CSTR) for Grignard formation and continuous crystallization as well as a PFR for the addition to an electrophile is reviewed. Emerging continuous manufacturing process opportunities arising out of the development of 3D printed reactors are also highlighted.
This White Paper reviews opportunities to accelerate development workflow, optimize purity and yield, and reduce capital investment through the application of modular concepts for the continuous manufacturing of APIs or advanced intermediates under cGMP conditions. A new modular continuous plant (MCP) with sufficient design versatility to facilitate rapid, cost-effective manufacturing under cGMP conditions is discussed. As a case study, the development of continuous manufacturing process utilizing Continued Stirred Tank Reactors (CSTR) for Grignard formation and continuous crystallization as well as a PFR for the addition to an electrophile is reviewed. Emerging continuous manufacturing process opportunities arising out of the development of 3D printed reactors are also highlighted.
Biologics are here to stay. Those seeing approval have begun extending beyond monoclonal antibodies to include more complex designs such as antibody-drug conjugates. Purification methods vary between biomolecule designs but chromatography is the dominant process.
This whitepaper introduces readers both to the chromatography modes that are typically used for biomolecule purification, and to those used at the analytical scale for quality control purposes.
Speed to market and development efficiency have long been drivers in the pharmaceutical industry but these factors have become more important than ever, given the changing landscape of markets. This “need for speed” is particularly important as accelerated development timelines and accelerated approval mechanisms become more common. The timely manufacture and delivery of drug product for clinical trials becomes essential, particularly for complex molecules such as high-potency active pharmaceutical ingredients (HPAPIs).
Successfully completing an organic synthesis involves three typically lengthy, but crucial steps: reaction monitoring, compound identification, and purification. These steps can create bottlenecks in the synthesis, unless a purpose-built, streamlined, and reliable workflow is on hand.
This whitepaper delves into some of the challenges faced by synthetic organic chemists as they navigate compound identification and purification struggles. It also describes how using a workflow that couples thin layer chromatography (TLC) and mass spectrometry (MS) to flash purification can help increase the efficiency of the entire process.
As the world moves towards increased automation, electronic record-keeping, and cloud connectivity, there is also significant innovation in communication tools. For chemists, these innovations are bringing about revolutionary changes in how they share their research.
Learn how innovative software can empower today’s chemists to search, reuse, and report their ChemDraw data efficiently and seamlessly. This whitepaper delves into the current communication struggles in chemistry research and how they can be easily overcome with purpose-built, innovative software.
Biogenic amines are naturally occurring organic bases formed by fermentation processes or bacterial decarboxylation of amino acids. As they can be an indicator of poor hygienic conditions and spoilage of food products, there is a need for analytical methods ensuring compliance with concentration limits. This application note describes a reliable method for the direct analysis of biogenic amines using LC/MS. Ion pair chromatography is used to gain separation of biogenic amines on a reversed phase column avoiding the need of a time-consuming and unspecific derivatization procedure. Exemplary, a Tempranillo red wine is evaluated regarding toxicological thresholds of biogenic amines stated by the European Food Safety Authority.
The field of native mass spectrometry has advanced significantly over the past several years. Integration of a powerful online separation can advance the field of native mass spectrometry even further. Capillary Electrophoresis (CE), coupled via ESI, is a natural fit for native mass spec analysis because it can be performed in native solvent conditions without concern for interactions with a chromatographic stationary phase. Here we highlight the unique capabilities of a fully integrated microfluidic CE-ESI platform for native protein analysis by demonstrating the high-resolution separation of charge variants of a monoclonal antibody along with two different examples of native protein complex analysis.
The number of technology platforms utilized in the chemical synthesis of actives, intermediates and other complex substances across pharmaceutical and biotechnology markets has rapidly expanded since . Prior to that time, most small molecule APIs were relatively simply, and could be manufactured with ‘classical’ chemistry technologies. However today, many small molecule APIs in clinical development require multiple advanced technologies for a single synthetic sequence.
Examples include high potency APIs, continuous processes, synthesis and conjugation with PEGs and mPEGs, carbohydrate chemistry, polymer APIs, microbial fermentation, biocatalysis, and cryogenic chemistry. It is challenging for any single pharmaceutical company or contract manufacturing organization (CMO) to develop a portfolio of advanced technologies that can accommodate the needs of all process steps involved in the production of such complex APIs.
Given the importance of glycosylation to overall performance of a glycoprotein, there is a need to completely characterize and then monitor these glycans for both research and manufacturing purposes. Traditional methods of analysis rely on cleavage of the glycans from the protein backbone, label with a UV- or fluorescence based tag, and separation and identification of the glycans by HPLC/MS. Following identification, the subsequent characterization and routine monitoring can be done using HPLC/UV or HPLC/fluorescence.
However, since the glycans attached to any protein come from a known set of glycans, the goal of this work was to develop and optimize a universal method to separate and completely characterize all potential glycans from any protein. This may entail a long, comprehensive analysis, which is acceptable since the characterization is done only a few times during product development. A second goal was to develop a rapid, routine method to be used for monitoring and control during process development or final manufacturing.
Per- and Polyfluorinated Alkyl Substances (PFAS) are a group of anthropogenic chemicals that are highly stable and resistant to degradation. These chemicals are manufactured and used in many consumer and industrial products. As these PFAS compounds are persistent, toxic and potentially harmful to humans, the leaching and presence of PFAS in our environment have raised serious concerns globally.
This white paper summarizes the state-of-the-art analytical methods for monitoring PFAS and demonstrates the use, speed and performance of Ultra-fast Mass Spectrometry (UFMS™) for PFAS analysis in environmental waters. The described method consists of a simple methanol dilution, followed by a direct injection to LC-MS/MS, for rapid, reliable and highly sensitive quantitation of PFAS in environmental waters.
“I’ve had ChemDraw for so many years, I already know the best ways to use it.”
From a customer
This paper is about the ten tips and tricks – five old favorites and five new ones – that ChemDraw fans might have missed. Mainly because there are so many tips and tricks available in ChemDraw that it is difficult to know everything. Plus, there’s always a powerful, new release coming out so new functionality can go unnoticed.
Routine laboratories are the analytical facilities that continually strive to keep our water, food, medicine, and consumer goods safe, effective, and authentic. Over the years, the pressures on these labs has steadily increased because of spiraling operational and staffing costs, ever-more complex analyses, and the need to stay abreast of changing technology.
This eBook shares some of the unique, sophisticated, and sometimes space-travel worthy, liquid chromatography solutions that Agilent has developed to assist analytical scientists in their work. The Agilent InfinityLab LC Solutions described here include those that increase sample throughput, boost uptime, and maximize space utilization. Every single tool was designed to be robust, intuitive, and a joy to use, and ultimately, to boost lab productivity, profits, and employee satisfaction.
This whitepaper takes a look at how artificial intelligence (AI) has revolutionized the scientific research lab, with a focus on high-performance liquid chromatography (HPLC). Readers will get a chance to learn how and why labs have begun to adapt to these advances in autonomous analytical instrumentation.
AI has the potential to play a powerful role in automating HPLC. As developers are working to incorporate analytical intelligence into modern HPLCs, it’s a great time for researchers in the field to find out how AI can change chromatography as they know it—from optimizing methods to remote monitoring and auto-diagnostic capabilities.
Colloidal silica’s diverse range of uses in research and in industry continues to expand. These nanoscale particles of amorphous silica boast a range of attributes, such as high stability, hardness and excellent binding ability, thanks to the tunable chemistry of the particles’ silanol-rich surface. Applications for colloidal silica now range from metal-casting molds to drug-resistant bacterial biofilms. Find out how scientists are using colloidal silica to address critical global challenges.
Fused-Core® columns can deliver both fast and high resolution separations that allow chromatographers to choose the best combination of particle size and column geometry appropriate for their methods and their instrumentation. The application of 2 μm columns using appropriate instrumentation provides more separation power than previously available using 2.7 μm SPP columns. For ultra-fast, high-throughput separations of samples in 96–384 well plates, ultra-high resolution separations of impurities in new and generic pharmaceuticals, complex environmental sample separations and challenging LC-MS separations, Fused-Core columns can deliver superior results, both accurately and reproducibly, in a timely manner.
Flash column chromatography is the preferred purification technique for many applications since it is a highly efficient method that provides chemists with a large variety of variables to manipulate to accomplish the desired level of purity. Whether you are an organic or medicinal chemist, are screening natural products, or working with peptides, this white paper gives you clear guidance in how to succeed in purifying your target compound.
The influx of poorly soluble compounds into the drug development pipeline is likely to continue unabated. Solid dispersions provide a formulation technique that is well-suited to help tackle solubility challenges. But are they a universal approach for all drug substances? This expert review presents strategies for selecting a suitable formulation technique for poorly soluble drugs and describes in detail the characteristics of amorphous solid dispersions (ASD), and methods of manufacturing including spray-drying and hot melt extrusion. Recent advances in screening and modelling techniques for predicting solubility are also discussed. In addition, details of commercial products using ASDs and an upward trend in the approval of solid dispersion-based formulations is highlighted.
There are more than 20 different commercially available grades of high purity water, plus equipment and technology for producing these water grades in-house.
This white paper is intended to help readers navigate the selection process for many different grades of high purity water and their various applications, and to help determine whether to produce the required water in-house or to outsource.
Adhesives are indispensable in the automotive, aeronautic, and medical industries, among others. Modern adhesives are complex, and their quality requires an assessment of initial components as well as the final product. Molecular spectroscopy approaches, including FTIR and Raman, can be used to identify the components of a sample within seconds without any sample preparation, reagents, or consumables, offering a fast and effective route to glue analysis. Microspectroscopy can detect defects and inclusions on adhesive surface, while confocal Raman microscoscopy provides a unique capability: to analyze materials in depth without the need for a cross-section.
In this white paper we look at reverse engineering existing drug products using Raman imaging. We show that the Renishaw RA802 Pharmaceutical Analyser can be used to successfully characterize innovator and generic products and facilitate deformulation activities, and can characterize the components, concentrations, particle sizes and distributions of the innovator formulation, allowing generic followers to adjust their processes in order to create equivalent products, or products which are strategically different.
Fourier Transform Infrared (FTIR) spectroscopy is a very sensitive method that has been successfully employed in the field of protein biochemistry. This method allows for the accurate characterization of the secondary structure of proteins in aqueous solutions as well as the identification and quantification of conformational changes. FTIR spectroscopy has proven to be very useful, especially in the field of pharmaceutical formulation of therapeutic proteins, such as Antibodies. Further, the routine determination of protein stability under varying conditions is a challenging task that is important for assessing long-term viability.
Liquid chromatography (LC) is a powerful technique for the separation, identification, and quantification of target analytes in complex media such as biomatrices. LC offers target assay flexibility, multiple detection modes, and can be highly automated — all of these are ideal features to be applied to the analysis of high sample numbers or for research purposes in the modern clinical laboratory.
With the introduction of ever-more-powerful and easier-to-use mass spectrometry (MS) detectors at an affordable price point, LC-MS has become increasingly influential as a routine, investigative tool for clinical testing, therapeutic/dose monitoring, and the screening of disease states including quantitative and qualitative biomarker profiling.
Evaporation is one of the most common tasks performed in a chemistry laboratory. But how do you go about selecting the correct vacuum pump for your rotary evaporator? Or, if you already have a vacuum pump, how do you know whether it is well-suited for this application? The key to correctly selecting and sizing a vacuum pump for rotary evaporation can be found in your answers to the four questions posed in this Application Note.
Automation in chemistry can repeatably and reliably perform chemical reactions at a reduced reaction scale. These attributes enable the researcher to explore a larger set of chemical reaction conditions for DoE, solubility, reaction screening and process optimization to name a few.
We present five examples of how automation solutions from Unchained Labs can be used by chemists to more thoroughly, quickly, and efficiently discover new reaction paths and conditions.
This whitepaper aims to provide pharmaceutical researchers a better understanding of the uses and benefits of hybrid silica-based supports in HPLC separations of drug compounds. In a quick, absorbing read that includes commentary from a number of experts in the field, readers can find out how hybrid silica-based chromatography rose to popularity in the pharma lab, and why. The many benefits of hybrid silica materials are compared and contrasted with traditional silica usage, supported by references and examples from end users.
Inexpensive compact mass spectrometers are expected to continue their charge into university teaching laboratories, where their speed, usability and robustness are enabling – in many cases, for the first time – undergraduate students to have hands-on experience with an instrument that they are increasingly likely to encounter if they progress through a scientific career.
Aqueous colloidal silica, essentially made of just sand and water, is turning up in surprising ways at the forefront of research. A new collection of case studies highlights some of the exciting ways academic researchers are using colloidal silica to expand the frontiers of materials science. Nano-zeolites, bijels, and soft robots are among the novel applications featured in this new ebook: “Colloidal Silica: Small Particles, Enormous Potential”.
Identification and quantification of impurities in pharmaceuticals is critical throughout drug development and manufacture to ensure product quality. There are significant risks when using a qualitative certified reference standard for a quantitative analysis. Learn how the characterization of reference standards can dramatically reduce the risk of out of specification investigations, lengthy toxicity studies, and even the loss of entire batches.
The following is an excerpt from a presentation given by Lee Walko, USB consultant and biobased business development director with Omni Tech International, Ltd., at the Eastern Coatings Show . The presentation includes the basics of soy chemistry in coatings, including the structure of a soy oil triglyceride, some reasons why soy is used in coatings, the basic building blocks of soy in coatings and future possibilities.
As pharmaceutical companies have shifted their development focus to large-molecule biotherapeutics, the ability to separate intact monoclonal antibodies and antibody-drug conjugates for characterization purposes has become extremely important. To enable this characterization work, new LC particle technology has been required. The large Å pore size of the superficially porous particles used for RPLC described herein enables full access to the bonded phase surface for larger biomolecules. This improved access to the bonded surface produces narrower peak widths and enhanced resolution of minor mAb variants, and can lead to increased retention under most analysis conditions. Together, with new mass spectrometric instrumentation and software, wide-pore superficially porous particle LC columns will greatly aid in the advancement of large-molecule biopharmaceutical characterization and development. The recent expansion of the very large pore superficially porous particle family to include three bonded phases (C4, C18, Diphenyl) permits very high resolution separations of lower abundance protein variants, permitting structure analysis and quantification of these variants.
Rotary evaporators are the workhorse machines of organic chemistry, from academic labs to pharmaceutical R&D and the rapidly growing cannabis oil industry. The fundamental design of rotavaps had changed little over the past 50 years.
Now, a new rotavap design, based on a highly efficient combined chiller/condenser unit, has been developed by US company Ecodyst. The Ecodyst is compact, fast, efficient, and readily scalable from research- to industrial-scale.
Researchers typically avoid using affinity tags in the purification of therapeutic proteins. Recently, one very short affinity tag—just four amino acids long—proved its worth for purifying a malaria vaccine candidate for clinical trials. This has opened the door to a range of novel protein-based malaria vaccine candidates, which are now either in or progressing toward clinical trials.
In all types of modern laboratories, it is increasingly important to be able to carry out accurate and reproducible HPLC analyses with excellent turnaround time and throughput. For those laboratories that must develop, validate, and use methods over a significant period of time, or those that must transfer methods to other laboratories around the world, it is a practical business advantage to be able to develop robust and rugged methods more quickly. For both of these situations, it can be beneficial to have a diverse group of column chemistries from which one can choose and use to explore chromatographic selectivity.
Intact mass analysis is a key characterization step for any therapeutic protein of interest as a prospective biologic drug. This whitepaper describes the latest approaches for optimizing intact mass analysis using separations-coupled MS.
The whitepaper describes the latest advances in methods, hardware, and software for intact mass analysis. It desribes how these advances could be combined to further push the boundaries for intact mass analysis for complex heterogenous biologic samples.
Hydrogen peroxide and peracetic acid are versatile oxidizing agents that combine powerful oxidation with exceptional environmental compatibility. Their bona fide green chemistry credentials should help every modern chemist appreciate their potential applications. This comprehensive ebook delves into the myriad applications for hydrogen peroxide and peracetic acid, with chapters highlighting their role in chemical synthesis, aseptic packaging, and environmental applications such as wastewater treatment.
This ebook can be downloaded in its entirety or as individual chapters. The chapters cover the roles of hydrogen peroxide and peracetic acid in chemical synthesis, aseptic packaging and wastewater treatment. Please choose if you would like to download the entire ebook or one of the chapters.
Pharmaceutical or biotechnology companies looking to outsource their API production are planning for success by looking at the entire development cycle. The growing desire to select one API partner to work with throughout the drug development process, and to potentially also synthesize commercial quantities, puts an increased importance on the selection process.
This white paper highlights six key points that pharmaceutical and biotechnology companies should keep in mind when looking to select the ideal partner to synthesize an API for them—and ensure their drug development process stays on the path to success.
A drug discovery research project can be made more efficient, with reduced costs and increased likelihood for success, through optimal handling of the diverse information the project generates. The discovery team is inherently data driven, and the volume of data generated is often overwhelming, discipline-specific, and difficult to interpret. Modern informatics systems can help make that data conveniently available, and user friendly visualization renders it readily interpretable by all members of the project team.
Liquid chromatography and mass spectrometery (LC-MS) have transformed the field of proteomics, enabling researchers to rapidly survey the contents of complex biological samples. However, until relatively recently it has proven challenging and labor-intensive to perform accurate comparisons across multiple samples.
Tandem mass tags (TMT) have proven to be a transformative tool in this regard. Using TMT technology, researchers can add isobaric labels to multiple samples, which can then be analyzed in a single tandem MS experiment. These capabilities are making it possible to sensitively detect rare peptide species, to identify differences between healthy and diseased tissue, and conduct sophisticated surveys of the cellular proteome. This ebook provides an overview of the TMT technology, and offers five case studies that illustrate some of the cutting-edge applications for which these reagents are being used.
The genome has given clinical researchers a powerful tool for understanding the biological foundations of many diseases, but it only tells part of the story. This ebook shows how different laboratories are employing mass spectrometry and other cutting-edge tools to collect richer datasets based on a combination of multiple ‘omes,’ including the proteome, metabolome and transcriptome.
Through the integrated analysis of these molecular profiles, researchers can glean insights that would be impossible to obtain with any one dataset alone—for example, the mutations in the genome can be a poor predictor of actual gene expression or protein production. The case reports presented in this collection show how these multi-omic analyses can potentially lead to earlier and more accurate research predictions, and ultimately, to possible individualized treatment regimens.
As plastics continue to enter the environment, understanding their global impact is vital to addressing microplastic pollution. Since its emergence as an environmental and potential human health threat, researchers have strived to develop tools for accurately measuring microplastics in environmental and food matrices using FTIR-based techniques and automated data handling.
This study examines the current status of methods of microplastic quantification and identification and presents the analysis of microplastics smaller than 10 microns in a sample of soil from a marina using FTIR imaging, combined with a free software program, MPhunter.
As plastics continue to enter the environment, understanding their global impact is vital to addressing microplastic pollution. Since its emergence as an environmental and potential human health threat, researchers have strived to develop tools for accurately measuring microplastics in environmental and food matrices using FTIR-based techniques and automated data handling.
This study examines the current status of methods of microplastic quantification and identification and presents the analysis of microplastics smaller than 10 microns in a sample of soil from a marina using FTIR imaging, combined with a free software program, MPhunter.
A surprisingly large number of materials have unpaired electrons. These include free radicals, many transition metal ions, and defects in materials. Free radicals are often short-lived, but play crucial roles in many significant processes such as photosynthesis, oxidation, catalysis, and polymerization reactions.
Electron paramagnetic resonance (EPR) spectroscopy is the only method for the direct detection of species that have unpaired electrons, and its applications span one of the widest ranges of any analytical technique.
Monoclonal antibody (mAb) therapeutics have been widely used to treat various diseases, including cancer. Oftentimes, dimers and other high molecular weight aggregates are present in the mAb therapeutics, leading to reduced biological activity. Traditionally-used methods for aggregate removal rely heavily on anion exchange chromatography (AEX) in flow-through mode followed by a generic bind/elute polishing step. While there are several advantages associated with these methods, they are often time-consuming and expensive. This whitepaper reports the use of hydrophobic interaction chromatography (HIC) in lieu of the generic bind/elute polishing step, for the removal of aggregates from mAb therapeutics. HIC is a more simple and cost-effective method, leading to higher selectivity towards mAb aggregate removal.
There are currently a half-dozen different insulin analogues on the market. These differ from each other and from natural insulin by just a few amino acids, but exhibit markedly different pharmacokinetic and pharmacodynamic properties. Liquid chromatography and mass spectrometry (LC-MS) offers a powerful tool for the sensitive and quantitative detection and discrimination of these highly similar recombinant proteins. This whitepaper reviews the considerations that analytical chemists should take into account when planning to undertake LC-MS analysis of an insulin analogue-containing specimen.
This study describes a new method of quantifying different types of microplastics in environmental samples using FTIR imaging. The method utilized was able to successfully recover, identify, and quantify microplastics in organic-rich samples such as sediment, water, and fish.
The method utilized FTIR imaging, combined with the MPhunter software and proved to be a rapid and accurate way to automatically identify and quantify microplastics and other materials. Combined with H2O2 oxidation, FTIR imaging is a strong candidate to be a standard method in microplastic analysis, allowing further study and understanding of microplastics in the environment
Pharmaceuticals play a prominent role worldwide. This widespread presence is met with regulatory requirements at each phase of pharmaceutical development and manufacturing—from inspection of raw materials to quality control of final products. Consistently producing pharmaceuticals that both continue to satisfy the consumer and adhere to regulatory mandates, requires analytical methods, instruments, and systems that ensure quality standards are upheld throughout the pharmaceutical industry. In the following chapters, you will discover relevant analytical techniques, useful industry examples, and tips for assuring continued compliance with the latest regulations.
The use of microbial fermentation to make biologics is growing rapidly. A manufacturing platform is an increasingly popular way to speed up process development stages and get a biologic to market faster. High-throughput systems can speed up optimization of each of these platform steps. Single-use, disposable technologies are starting to replace stainless steel to streamline biologic manufacturing, reduce costs, minimize contamination risks and allow rapid expansion of capacity.
For many years pharmaceutical companies have taken a deliberate approach for creating new small molecule drugs for disease treatment. These new chemical entities and their analogs were often synthesized in large numbers and then tested for efficacy for treatment of various diseases. With the small molecule drug hit rate dropping and with recombinant protein synthesis becoming available and growing explosively, it became possible to manufacture biopharmaceuticals which could be used to treat diseases that could not have been considered previously. Many pharmaceutical companies have focused more and more of their efforts in this area, and new biopharma companies have grown around this important area. A number of large, small molecule-focused pharmaceutical companies have also purchased or merged with startup biopharmaceutical companies to acquire their pipelines and their expertise.
Ongoing evolution of new designer drugs, also known as new psychoactive substances (NPS), requires continuous updating of screening methods when determining the suspected role of NPS in deaths. The open library concept of the Toxtyper system allows for rapid updates of methods linked to the appearance of new drugs. The following application note describes the development and validation of a sensitive screening method for the identification of the common prescription analgesics (e.g. oxycodone, methadone and buprenorphine) together with illicit substances such as fentanyl, beta-Hydroxythiofentanyl and other fentanyl analogs with detection limits in sub-ppb to low ppb range.
The dominant technology of modern proteomics is certainly liquid chromatography-mass spectrometry (LC-MS). However, it is safe to say that the primary discussion point in terms of technology in proteomics has been the mass spectrometry part of this partnership. A great deal of emphasis is placed on the mass spectrometer and the data generated by it.
However, there has been less focus and emphasis placed on the separations of peptides and proteins prior to analysis by mass spectrometry in terms of the nano-LC chromatography systems and columns contributing to proteomics performance. One half of the LC-MS combination has been neglected.
Therefore it seemed to the authors that it was time this imbalance was redressed. The following handbook has been produced in an attempt to educate and inform on the relevance and significance to proteomics of liquid chromatography, in particular reversed-phase nano-LC directly coupled to MS.
The coatings industry, just like every other segment of the chemical industry, is innovating in response to new and expanding environmental regulations. As one of the world's biggest users of chemical ingredients, coatings manufacturers are under intense pressure to meet new standards but also provide affordable and efficient products. Innovative companies have responded with new additives that help achieve goals such as reducing levels of hazardous air pollutants (HAPs) and volatile organic compounds (VOC), as well as making certain that coatings that come in contact with foods are up to today's safety standards.
The benefit of therapeutic antibodies is their ability to be inherently more selective than traditional small-molecule pharmaceuticals through specific binding activities, lower toxicity, and higher efficacy. And the proof of their benefits is in the numbers: The U.S. Food & Drug Administration approved 68 such therapeutics by the beginning of ,and more than 50 are being evaluated in late-stage clinical studies for a range of indications.
Because mAbs are produced from cell lines and fermentation processes, they are fundamentally less pure than traditional chemically synthesized products and are subject to possible degradation and chemical modifications throughout their manufacturing and storage. This lack of purity and the microheterogeneity inherent in the nature of the molecule (due to, for example, glycosylation) require significant and robust characterization not only during discovery and research but also throughout the drug development process, quality control, and lot release to ensure safety, efficacy, and consistency.
This whitepaper explores how LC/MS analysis of intact therapeutic antibodies can be performed with high accuracy and sensitivity down to subnanogram levels for molecular weight confirmation and assessment of isoform pattern. For the analysis of more complex molecules, such as antibody-drug conjugates, native mass spectrometry is beneficial to characterize the sample and obtain the accurate drug-to-antibody ration.
In the 21st century, chemical R&D creates a deluge of analytical data from instrumentation. Regulatory submissions and critical decisions are based on the data. When data can't be accessed in standard formats, decision-making and problem-solving become hard, if not impossible. To improve access to analytical data while maintaining their integrity, organizations have to be able to standardize, homogenize, and digitize data to help with scientific innovation. This whitepaper explores efforts in standardization, homogenization and digitization of analytical data.
The total cost of bringing a drug to market is now estimated at about $2.5 billion, and the pressure to advance new drugs faster is greater than ever. Part of the challenge is the rising expense of late stage drug testing, which now typically costs several hundred million dollars. But developers can speed their drugs to market more easily if they learn more about a candidate drug’s chemical characteristics as early in the development as possible. The goal is to invest as little as possible before the drug candidate has proven it’s potential.
Analytical testing across the broad commercial range of consumer products is essential to ensure the safety of end users, support the continuous supply of quality offerings to the marketplace, protect a company’s brand and reputation, and meet regulatory requirements. Product recalls and failures are costly. A company can suffer enormous tangible and intangible losses. The adoption of new analytical methods and technologies can enable companies to maximize the accuracy, cost-efficiency, and productivity of risk assessment and ongoing monitoring of product safety and quality.
In this white paper, it will be demonstrated that the use of three HILIC phases, which provide very different and complementary selectivity to one another, is both practical and effective for HILIC method development. These selectivity differences can be exploited, together with mobile phase pH, to thoroughly explore selectivity and to enable selection of an appropriate stationary phase/mobile phase combination during HILIC method development. A systematic, step-by-step approach to method development is recommended to make it easier for chromatographers to develop new HILIC methods in a productive manner.
Compact mass spectrometers (CMS) have revolutionized reaction monitoring, turning a once laborious and time-consuming task into a rapid and convenient process with instruments right at the chemist's bench or fume hood. These instrument can provide results in as few as 30 seconds, are cost-effective, and offer a growing number of sample techniques. This report reviews the advantages and applications of CMS systems as well as some case studies in their use.
Measuring viscosity is a tried and true technique for characterizing fluids. But frequently viscosity measurements are not made correctly and accordingly do not provide reliable or meaningful information.
Viscosity is a parameter used to describe the flow properties of fluids. Measurement takes place by applying a force to the fluid and measuring the resulting flow. So, if a sample does not flow, viscosity is not the best parameter to describe its physical properties.
The agrochemicals industry has come under increasing pressure to bring to market new, less costly, and highly effective crop protection products with reduced environmental footprint compared to traditional herbicides and pesticides. To respond to these challenges, agrochemicals manufacturers are exploring novel ways to innovate across the research and development pipeline. They are experimenting with cost-saving efficiencies in product development, scale-up, and manufacturing, and a variety of improvements to increase the speed and accuracy of analytical processes to enhance productivity. This white paper examines innovative methods and technologies available to improve the analytical workflow for producing next-generation agrochemicals by describing the real-world application in the analysis of crop protection products.
The pharmaceutical and biopharma industry continues to experience solid growth in an expanding global market. This market growth has been accompanied by an ever-changing industry landscape, with consolidation among long-time "big pharma" leaders, ongoing mergers and acquisitions, and the emergence of start-ups and technology-based offshoots from academic laboratories. As the industry continuously adapts to evolving market pressures -- whether medical, economic, or demographic in nature -- the trend toward outsourcing of Active Pharmaceutical Ingredient (API) & Drug Product (DP) manufacturing to (Contract Manufacturing Organizations) CMOs with specialized capabilities, expertise and infrastructure remains a strong one.
The emergence of new and increasingly complex synthetic biopolymers, novel polymers, and polymer additives with a broad range of structural and compositional diversity has been a driving force in the development of advanced separation and analytical technologies for polymer characterization. Today analysts seek innovative techniques that allow them to detect and identify components of interest in highly complex samples with high sensitivity and to quantify components at the low levels required by regulation. Achieving these goals present numerous challenges, including the potential for large variation in sample concentrations, the presence of components of interest at trace levels, and increasingly complex mixtures comprised of new types of novel “green” and bio-based polymers.
Laboratory based organizations face a wide variety of unaddressed data management challenges, and yet ultimately their scientific data is the currency with which they trade. Proper data management may not pay shareholders but it fundamentally defines the integrity of the organization and purpose for existing. Being the cheapest, the fastest or most definitive is desirable but is meaningless if data is untrustworthy.
Proteomics techniques are rapidly evolving to become a highly sensitive, quantitative, and high-throughput approach to analyzing global protein dynamics within a cell, tissue or an organism.
The ability to perform accurate protein quantification at low levels lets scientists unravel the complexity of protein interactions and track abundance changes in a variety of targets. When combined with multiplexing capabilities that allow scientists to measure increasing numbers of samples across varying conditions in a single experiment, quantitative proteomics provides a better understanding of the molecular mechanisms underlying biological processes and disease states.
This whitepaper discusses critical advances in analytical technology driving this revolution in proteomic analysis, allowing biologists to explore the proteome at greater depth, measure changes in protein localization and quantify minute changes in low abundance proteins. Furthermore, four leading researchers discuss the use of tandem mass tag (TMT) multiplexing enabled by Synchronous Precursor Selection (SPS) MS3, and how it has facilitated groundbreaking discoveries in each area of their research.
Genotoxic impurities (GTIs) are intermediates or reactants that can develop during the synthesis of a drug substance. In addition to process impurities, certain drugs may generate GTIs via degradation during formulation or storage. The genotoxic compounds have the potential to react with DNA, which could consequently cause a carcinogenic response and tumor development. It is therefore essential to identify the presence of these impurities early in the drug development process, and to have reliable and highly sensitive methods for their accurate determination in both drug substance and drug product.
There is growing need for research groups to adopt a Laboratory Information Management System (LIMS). A reliable, flexible and easy-to-use LIMS is an increasingly essential research tool that enables investigators to preserve data, results and experimental protocols; share findings with collaborators in other (sometimes far-flung) locations; and to document milestones in research and discovery that can have critical implications for establishing patents and priority of discovery. Even if groups already utilize an incumbent management system, there are many good reasons to consider selecting a new commercial LIMS. This white paper from StarLIMS lays out several important criteria that should be taken into account when evaluating a new LIMS for your group or laboratory.
Manufacturers of pharmaceuticals, drug delivery systems, and biomedical devices have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls). E&Ls may be inherently toxic or may contaminate or interact with drug products, posing a potential danger to patients. Even as regulatory guidance related to the application, performance, and reporting of E&L studies increases and examples and data accumulate, E&L analysis is still an evolving area of investigation. This whitepaper provides an overview of the current best practices in the analysis of E&Ls, including the basic principles of E&L analysis, how to design an E&L study, and a detailed look at workflows, focusing on analytical techniques and instrumentation, sample selection, and extraction conditions. The discussion also highlights the advantages and limitations of available and emerging separation, detection, and identification technologies, software tools, and quantitative methods development.
End-to-end automation of an integrated liquid chromatography-mass spectrometry (LC-MS) workflow for target screening applications is readily achievable and yields substantial advantages. An automated, robust platform that combines high quality target mass interpretation with fast analysis times can boost the efficiency and productivity of drug discovery laboratories. Thermo Fisher Scientific has designed and implemented an automated LC-MS workflow optimized for accurate target mass interpretation. Under the control of the Thermo Scientific™ Dionex™ Chromeleon™ Chromatography Data System (CDS) software, this customized, fully automated workflow is in operation at Bayer Pharma AG, with a reported success of finding the target mass in about 90% of more than 9,000 reaction controls studied to date.
Herein we describe a robust and efficient LC-MS workflow for high-throughput target mass analysis. It combines ultra-high performance liquid chromatography (UHPLC) and high resolution MS capable of accurate mass analysis and rapid compound identification and quantification. State-of-the-art Chromeleon CDS software synchronizes and controls the system components, ensuring a seamless workflow from the set-up and initiation of a screening run through data analysis and results reporting.
The constant need to develop more rapid and cost-effective technologies for accurate, sensitive and specific detection in biological samples is a driving force behind the integration of new sample preparation tools, automation and informatics across the bioanalytical workflow. These technologies have potential applications in different fields of research ranging from microbiology, toxicology and medicinal chemistry to the pharmaceutical and cosmetic industries,1 as well as food and environmental safety.2 We present the design characteristics, operational features and key advantages of a new digital, time-lapse, bright field technology with demonstrated uses and great potential across a range of applications involving bioanalysis of microbial and mammalian cells.
Cannabis testing is a rapidly growing business expected to exceed $8 billion in . It is fueled by many factors including consumer demand, evolving legislation, and growing evidence of the benefits of medical marijuana, which is now legal in 23 states and the District of Columbia. Numerous other states are currently considering efforts to legalize cannabis for medical purposes. Accurate and reliable testing for the hundreds of compounds in marijuana strains,especially regarding potency and safety, is critical. This White Paper provides a broad overview of the latest research and attitudes towards marijuana, and focuses on the key lab and technical considerations that are required for successful cannabis testing.
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