Contract developers and manufacturers of active pharmaceutical ingredients (APIs) are now playing an even more fundamental role in contemporary drug development strategies.
A report by analyst firm visiongain forecasts that the overallpharmaceutical contract manufacturing market is growing fast, achieving revenues of $84.0 billion by at a compound annual growth rate of 6.4% from . The market, says visiongain analysts, is expected to continue to grow from to as more pharmaceutical companies strategically outsource manufacturing services.*
With the growing reliance on contract services and a fragmented landscape creating plenty of choice, it is more critical than ever to pick the right CDMO.
Where API strategy and procurement tactics intersect
Because most product plans are unique, choosing a small molecule API and drug substance manufacturer that can provide excellent quality, while routinely demonstrating supply reliability over a drug&#;s entire lifecycle, is worth a concerted effort. Finding a &#;perfect&#; partner to marry your drug strategy can be as challenging as it is critical to market success.
Critical qualities and attributes of strategic small molecule API partners
Pharma&#;s drug developers are increasingly sourcing APIs from CDMOs. These intellectual property owners have to evaluate a number of critical aspects in making their choice for such a strategic partnership, including the overall program&#;s financial viability. More and more current drug strategies hinge on the partner&#;s technical and operational capabilities and their experience synthesising the target compound in question. Most procurement professionals understand these competing priorities despite extreme pressure from their organizations to closely control program costs.
That&#;s why when selecting a partner to develop and manufacture small molecule APIs and meet strategic business interests, the decision to choose a supplier must be weighted appropriately among all the critical, strategic attributes a &#;perfect&#; API partner should have.
Here are six critical, strategic attributes to consider right up front when choosing a small molecule API partner:
1. Reliable supply chain
Great access to a well-executed quality supply chain is an essential attribute of any strategically important supplier. How well one&#;s API supplier manages its own raw material supply chain is a leading indicator. Any disruptions to your supplier&#;s supply chain and your API delivery may be delayed. Pfizer CentreOne, being embedded within Pfizer has direct access to one of the industry&#;s most developed, secure and reliable supply chains in the industry
2. Robust, relevant process expertise and experience
Drug development routes are getting more complicated and the APIs in high therapeutic demand are getting harder to make. Robust process development is paramount, but it has to be matched to deep science and process engineering acumen. This clearly extends to troubleshooting and refining synthesis to find new or better production and cost economies, as well as creating those more robust and effective processes that increase quality and reliability.
3. Knowledgeable in how to accelerate your product&#;s pace to market
Pharma understands that the more directly and succinctly a drug developer can manage a drug&#;s critical timelines on the way to market, the more successful the product will be financially, both in the near and far term.
Early, intensive synthesis analysis is one good way potential partners can add value. Pfizer CentreOne for example, was presented recently with a synthesis that was unsafe to reproduce even under the strictest of lab conditions and controls.
Within a very intensive timeframe, Pfizer chemists and process engineers were able to define a much more stable, scale-able chemistry to reliably make the high-value therapeutics being developed by the company
4. Great quality systems, operational excellence and the staff to back it up
Achieving critical quality attributes (CQAs) with consistency and transparency is certainly a prerequisite for any strategic supply relationship. But for pharma, it&#;s a fundamental requirement and a key performance indicator when assessing the potential for long-term reliability and quality when choosing a strategic API supplier.
For APIs of every kind, one common CQA denominator is the ability of your API developer and manufacturer to effectively, cost efficiently control contaminants or impurities during all primary and intermediary processing steps.
Another KPI is controlling and manipulating an API&#;s physical properties effectively is another KPI. A CDMO partner with the staff, technology and experience to evaluate and address your API&#;s physical properties for therapeutic action and other goals is intrinsically strategic. A supplier that can accurately engineer drug substance attributes to meet drug formulation and drug product (DP) targets early in a small molecule API program can often yield efficiencies to leverage later in the journey to market.
Lastly, when combined with a robust and repeatable process, &#;small molecule&#; API becomes &#;commercial-ready&#; API with a validated process well-proven and ready to go the distance over the drug product&#;s intended life-cycle.
5. An extremely conscious approach to sustainable industrial process
Thinking environmentally? Suppliers that can provide more stable, less volatile chemistries and efficient batching are more efficient. Those with experience optimizing processing methods that reduce or recycle intermediates and other hazardous by-products, are worth considering very carefully.
CDMOs that put an emphasis on delivering cleaner chemistries that reduce their impact on the environment through best-practice operations and technical mastery are better able to deliver project economies. With literally hundreds of CDMO partners to choose from, those that live core sustainability principles of re-use, recycle and reduce, are likely to be both great environmental stewards and the most cost-efficient processors.
6. A singular focus on continuous improvement, flexibility and intelligent collaboration
Processing API batch after batch, month after month, year-after-year may, over time, introduces complacencies and issues related to status-quo in process, operations and technology. If your chosen small molecule API manufacturer is not continuously focused on continuous process improvement, they may not be the perfect partner for strategic drug supply.
CDMOs with experience and vision will likely be able to bring an intelligent, collaborative approach to partnering and the insight needed to innovate solutions. Part of this comes from the talent and resourcefulness of the people who make your API and how they leverage the resources and technologies to assure the best outcomes of every batch. These attributes support creating an environment that is responsive, agile and more capable of performing over the long run.
Whatever your product&#;s market agenda might be, drug owner and drug maker often have to build a common base of knowledge and do it in a timely and prescribed manner. Better drugs begin with a better, smarter collaboration and the sooner both parties can achieve a true and transparent meeting of the minds, the better.
A strategic API partner will always be seeking ways to innovate and improve your compound or product&#;s value as part of the deal, and do it with the dedication of a partner, not a supplier.
Intermediate chemicals are essential in industrial processes and manufacturing. Their quality and availability directly impact the quality of your end products and the efficiency of your operations. Hence, selecting the right supplier is not just a decision; it&#;s a strategic move.
This guide will unpack the essential considerations when selecting an intermediate chemical supplier.
Intermediate chemicals are compounds formed as &#;stepping stones&#; in the journey from raw material to finished product.
Their role isn&#;t just limited to product formulation; they also enhance the overall efficacy of industrial operations.
These chemicals often serve as foundational components in a wide variety of products. Whether it&#;s pharmaceuticals, cosmetics, agrochemicals, or specialty chemicals, intermediates are the backbone that supports product formulation.
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Incorporating the right intermediates can optimize reaction pathways, reducing the number of steps or even enabling more energy-efficient reactions. This translates to quicker production cycles and reduced costs.
Intermediates can influence the performance attributes of the final product. For instance, in pharmaceuticals, an intermediate might play a role in enhancing the drug&#;s efficacy or stability.
Many industries have strict guidelines on product composition and quality.
Using specific, high-quality intermediate chemicals can assist in meeting these requirements, ensuring that the end products are safe and compliant.
As new materials and compounds are discovered, the role of intermediates evolves. They allow industries to innovate, release new products or enhance existing ones, by acting as the bridge between foundational chemistry and innovative application.
The production, sale, and purchase of intermediate chemicals form a significant portion of the global chemical industry&#;s economy. Their manufacture and trade create jobs, drive research, and support many downstream industries.
While many intermediate chemicals serve as steady building blocks in the production process, reactive intermediates are a class of their own.
They are transient species that exist momentarily during a chemical reaction, playing a pivotal role in the transition from reactants to products.
Incorporating reactive intermediates into your production process can be a game-changer, but it necessitates a supplier well-versed in their nuanced behavior and applications.
Intermediate chemicals are essential components in various industries and processes. A reliable catalyst manufacturing partner plays a crucial role in facilitating the production of these chemicals.
Here are some primary industries and processes that heavily rely on intermediate chemicals and, by extension, need a dependable catalyst manufacturer.
The creation of drugs often involves multiple stages, and intermediate chemicals are vital at each step. Catalysts speed up these reactions, ensuring drugs are produced efficiently.
Production of fertilizers, insecticides, herbicides, and other agricultural chemicals involves complex processes where both agro intermediate chemicals and catalysts are indispensable.
Oil and gas refining processes use intermediate chemicals to produce a wide range of products, from fuels to lubricants. Catalysts help in cracking and other refining operations.
The synthesis of various plastics and polymers requires specific intermediate chemicals. Catalysts ensure that these processes proceed at a feasible rate and temperature.
From the formulation of fragrances to the synthesis of specific compounds used in skincare, intermediate chemicals are crucial. Catalysts often play a role in synthesizing organic compounds in these products.
Intermediate chemicals are required for dye synthesis, finishing agents, and other treatments. Catalysts can optimize these reactions.
Semiconductors, insulators, and other components often require specialized chemicals in their manufacturing processes. Catalysts can facilitate these chemical reactions.
While direct addition is limited, intermediate chemicals play a role in food additives, preservatives, and flavoring agents&#; production. Catalysts aid in synthesizing some of these compounds.
These are produced in smaller quantities than commodities and have specific applications. Both intermediate chemicals and catalysts are integral to their production.
Catalysts play a role in reducing emissions in various industries. Intermediate chemicals can also be used in water treatment processes and waste management.
As industries move towards sustainable processes, intermediate chemicals derived from bio-based sources are on the rise. Catalysts aid in these green transformations.
These are chemicals produced in limited volumes and high purity levels. They require precise synthesis routes, often necessitating specific intermediate chemicals and catalysts.
Choosing the right supplier is essential for efficient operations, cost savings, and product quality.
Here are key factors to consider in making an informed decision.
Quality isn&#;t merely an indicator; it&#;s the very essence of a product. Ensure that your supplier emphasizes product purity and consistency. Look for certifications, industry standards, and testing methods they employ.
A supplier&#;s history often paints a clear picture of their competence. Investigate their on-time delivery metrics, adherence to product specifications, and, if possible, gather client testimonials or case studies.
Balancing cost with quality is crucial. Beyond mere price points, examine the potential for volume discounts, favorable contractual terms, and other financial incentives that could benefit your bottom line.
Technical glitches are inevitable. What matters is how your supplier responds to them. Gauge their technical prowess, their problem-solving capabilities, and the efficiency of their after-sales support.
Dig deep into the origins of your supplier&#;s products. Understand their sourcing methodologies, ensuring they are both reliable and sustainable. Also, probe into their contingency measures for disruptions.
In a dynamic market, flexibility is paramount. Your supplier should be capable of customizing products to meet specific requirements, adapting to order modifications, and even adjusting batch sizes.
In an era where sustainability is paramount, it&#;s essential to align with suppliers who prioritize green processes. Beyond this, ensure that the company practices ethical sourcing, manufacturing, and community engagement.
A supplier&#;s proximity can influence the efficiency of your operations. Beyond mere location, assess their warehousing capabilities, distribution network, and overall logistical prowess.
Innovation drives progress. A supplier that invests in R&D not only provides cutting-edge products but also opens avenues for collaborative projects, giving you a competitive edge.
While vetting potential suppliers, be on the lookout for inconsistencies in product quality, a lack of transparency in sourcing methods, or any reservations about their ethical standards. Recognizing these early can save you from costly pitfalls down the road.
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