CMC: Chemistry Manufacturing & Controls – But who's really in control?

In the complex world of pharmaceutical development and production, where groundbreaking innovations mix with logistical and supply chain puzzles, all eyes often turn to Chemistry Manufacturing & Control (CMC) – the vital link in bringing life-changing medicines from the lab to patients. Lately, this key aspect has been thrust into the spotlight with news of high-profile Contract Development and Manufacturing Organization (CDMO) acquisitions coinciding with numerous reports of Complete Response Letters (CRLs) being issued by the FDA to companies, as therapies hit snags in production, precipitating costly setbacks and frustrating delays in the delivery of indispensable treatments.

This therefore begs the question:
Who's truly in in control when it comes to CMC?

For medicine developers relying on CDMOs, this question looms large, especially with industry trends favoring prioritizing manufacturing capacity over the nitty-gritty of process development. But at the heart of it all, there's a realization that successful pharmaceutical production demands a delicate balance between the time spent on developing a process for manufacture, securing a slot in suitable manufacturing infrastructure, and getting the medicine to patients as quickly as possible – a balance that needs careful attention and expertise.

Each therapeutic brings its own set of challenges in process development, intricately tied to the complexities of chemistry, biology, scale-up, and manufacturing. Slip-ups in navigating these challenges don't just risk the quality of the product but can lead to expensive batch failures and hold-ups to the detriment of all interested stakeholders.

The Conventional CDMO Model

Driven by imperatives to optimize plant utilization and secure enduring contracts, the traditional CDMO model, often relegates the pivotal aspect of process development to the periphery. This leaves medicine developers vulnerable, trapped in alliances with CDMOs ill-equipped to furnish efficient and robust processes or provide comprehensive answers to CMC-related questions from the regulators, due to their limited comprehension of the underlying processes.

The fallout from this disconnect echoes throughout the industry, resulting in compromised product quality, regulatory headaches, and patients struggling to access vital medications. In this scenario, the question of who's really in control of CMC becomes more pressing – urging a rethink of priorities and partnerships.

To truly take charge in CMC, medicine developers need to reclaim ownership of the process development journey, forming partnerships rooted in transparency, collaboration, and a drive for excellence. This means moving beyond the old transactional mindset and embracing a "science-first" approach, where the importance of process development is recognized.

Process Portability

In turn, this opens up the concept of “Process Portability” – a paradigm shift in thinking about CMC strategy – providing the medicine owners with the ability to seamlessly transfer manufacturing processes across different facilities or locations without compromising quality or efficiency.

Incorporating “Process Portability” into CMC strategies also enhances adaptability and mitigates risks associated with disruptions such as CDMO acquisitions or unforeseen events like the COVID-19 pandemic. By investing in “Process Portability” initiatives, medicine developers can safeguard against supply chain vulnerabilities, ensuring uninterrupted access to essential medications for patients worldwide.

Such initiatives must be based on deep collaboration between medicine owners and manufacturing process developers - creating an environment where knowledge flows freely and insights are shared openly. And tapping into advanced modelling and digital solutions is a must, providing real-time access to process data and making quick decisions across the CMC journey.

How can medicine developers start - and regain - control in a landscape dominated by CDMOs?

The answer lies in proactive engagement, assertiveness and ensuring that the medicine owners also own the process required to make their medicines – thus enabling them to have Process Portability and putting them in the driver’s seat regarding where their medicine is manufactured. Medicine developers must actively seek out partners who prioritize process development and are committed to their success, rather than settling for transactional relationships focused solely on manufacturing capacity.

By taking ownership of the process development journey, medicine developers can ensure that their therapies are manufactured efficiently, reliably, and in compliance with regulatory standards. This proactive approach not only mitigates risks but also empowers medicine developers to bring their life-changing treatments to market faster, benefiting patients in need.

Ultimately, taking control of CMC is more than just overseeing operations – it's about embracing the concept of Process Portability, including mastering the nuances of the underlying processes used to manufacture these medicines to ensure that their life-changing impact can be felt by those who need them most.

In this journey, the true leaders are those willing to break from tradition, building alliances that prioritize scientific excellence, integrity, and, above all, patient well-being.

Learn more about Process Portability

Watch the Q&A session where APC Experts Define ‘Process Portability’