Chemistry, manufacturing, and controls (CMC) is central to modern drug development, ensuring drug quality, scalability, and timely availability to patients. However, successfully implementing CMC in drug development settings is often a challenge.
Image Credit: Design Space InPharmatics LLC
This article summarizes a discussion at LSX Biopharm America on September 11. A panel of industry experts discussed approaches to overcoming the most urgent CMC challenges during the discussion.
The panel featured industry leaders from the pharmaceutical and biotech sectors, who discussed these challenges and provided valuable insight into CMC nuances and avoiding common issues.
The panel comprised:
- Zeid Barakat, Partner at Scimitar Consulting (Moderator)
- Chase Orsello, Head of Bioprocess Development at Sanofi
- Johannes Roebers, Head of Product Development Division at PLG
- Dan Jacobs, Head of CMC Strategy and Operations at Pioneering Medicines
- Neera Jain, VP of Chemical and Pharmaceutical Development and Operations at Syros
- Federico Pollano, Business Development at Rentschler Biopharma
CMC: A strategic asset when properly implemented
Zeid Barakat began the discussion by highlighting how well-executed CMC can be a key strategic asset, enabling drug supply to reliably and rapidly reach patients. However, this process must be implemented correctly from the offset.
Federico Pollano discussed the importance of understanding regulatory requirements at an early stage.
This is an especially important consideration for start-ups and early-stage companies, who should develop a clear roadmap covering every aspect of drug development from initial development to late-stage market considerations.
The importance of early-stage CMC de-risking
Dan Jacobs discussed his experience at Pioneering Medicines, where the company prioritized early-stage CMC de-risking. He highlighted that companies should plan for the long term, even during the early phases of development. Recognizing and addressing CMC risk factors early on creates value while allowing companies to avoid potentially expensive surprises at later stages.
Johannes Roebers emphasized this point, providing an example involving a UK-based company that did not consider CMC early on, resulting in major delays and strategic mistakes.
Collaboration and communication are key
Neera Jain went on to discuss the importance of both internal and external collaboration. Decisions around dosing, formulation, and manufacturing involve ongoing dialogue among all stakeholders, including CMC teams and pharmacokinetics.
This collaborative approach allows companies to avoid overlooked critical CMC issues being discovered during late-stage clinical development.
Selecting the right CMO is critical
One of the most important decisions in drug development is selecting a Contract Manufacturing Organization (CMO).
Johannes Roebers highlighted how changing CMOs is often more expensive and difficult than expected, meaning thorough due diligence must be conducted from the start. He also stressed the need for site visits and in-depth engagement with CMO teams before deciding.
Neera Jain added that drug development companies should endeavor to be their CMO’s “best client,” nurturing a collaborative relationship beyond simple transactional exchanges.
Being a CMO’s best client means offering an identical level of support to that expected of supply partners, fostering a more robust collaboration to minimize production delays, and anticipating problems before they become critical issues.
Leveraging technology and AI
Chase Orsello from Sanofi outlined the potential of AI and machine learning in improving CMC processes. These technologies are still emerging, but they offer the potential to considerably reduce the time and expense commonly associated with drug development.
AI can help teams analyze huge datasets more efficiently, allowing them to streamline decision-making processes and identify risks earlier.
Conclusion
The panel’s discussion emphasized the complexities of CMC, highlighting the importance of employing a collaborative, strategic, and proactive approach.
The key takeaway of the discussion was that a CMC should be regarded as a critical driver of success in drug development rather than just a technical hurdle. This should be the case whether a drug developer is choosing the most suitable CMO, de-risking early-stage development, or leveraging the potential of AI in its work.
Acknowledgments
Produced from materials originally authored by Meranda Parascandola from Design Space InPharmatics LLC.
About Design Space InPharmatics LLC
DSI provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence.
Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represents the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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