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Manufacture Standards & Regulation, Small Molecules, Quality & Compliance, Facilities

A Continuous Cycle of Success

April 2019 marked the end of Scott Gottlieb’s highly active tenure as FDA Commissioner. Throughout his time in the role, he made it explicitly clear that continuous manufacturing (CM) was a key factor in supporting innovation and “modernizing the pharmaceutical industry” (1). The call has been echoed by many others within the FDA – and elsewhere in the industry too. Pharma companies, however, have been slow to leave batch manufacture behind. Four years ago, only one drug made with CM had been approved and the situation hasn’t improved much since; today, there are around five products approved by the FDA made using CM.

CM undoubtedly requires manufacturers to have a certain level of front-end knowledge in terms of the management of procedures that will result in a successful product launch. Transient solid formation in a batch reactor, for example, is hardly a cause for concern, as the mixture can simply be stirred and eventually the solid should redissolve. But when such a solid forms in a flow process, new challenges arise and manufacturers face delays as they attempt to unfoul their reactors and/or manage the shutdown and cleaning of their systems.

Once these types of teething issues are addressed, however, there are huge benefits to CM. The current batch manufacturing process is costly and lacks flexibility. With a smaller physical footprint, CM enables CMOs and other manufacturers, in principle, to produce final drug products seamlessly in a GMP compliant manner. To date, pharma companies seem more likely to accept CM in regard to tabletting – a low bar for the industry given that many tableting machines already run continuously. I firmly believe that more research effort is needed to improve CM for the development and manufacture of drug substances to de-risk this promising approach and enable broader adoption in the pharmaceutical industry. I’ve heard from many people that although there is strong interest in this area, many projects taking place in companies are running as skunkworks until decision makers can be convinced that it’s worth the investment. It’s also well known that in a highly regulated industry like pharma, it can be difficult and risky to change the manufacturing process for already marketed products. Consequently, it’s clear to me that CM will be more applicable to new chemical entities coming through the pipelines and for generics where the cost of production can be lowered.

It is highly encouraging that the FDA is keen to help companies implement a more continuous form of manufacture into their practice. In February of this year, the agency issued a draft policy that detailed the development and implementation of CM for brand, generic and over-the-counter drugs. It charged its Emerging Technologies Team with the task of aiding early CM adopters with resolving “implementation challenges and navigating the application review process for products made with these modern methods” (1).

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About the Author

David Thompson

David Thompson is a Professor of Organic Chemistry at Purdue University, Indiana US.

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