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The FDA’s unambiguously clear promotion of continuous manufacturing in the pharmaceutical industry is nothing new. Rather, a valid claim can be made that the agency has been actively supporting continuous manufacturing dating back to its 2004 FDA 21st Century Initiative, which was intended to encourage the pharmaceutical industry to adopt technological advances and implement risk-based quality management approaches. Industry collaboration, the incorporation of new manufacturing science into the regulatory paradigm and harmonization were prevailing goals of this initiative. Twenty-two years later, these objectives remain paramount, as the FDA continues to explore new ways to achieve its stated vision of “…an agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.” If we break this statement down into its components, it becomes clear why the agency embraces continuous manufacturing as its best opportunity to realize this vision.
Agile and flexible are not terms used to describe batch pharmaceutical development or manufacturing, where scale-up is required, decoupled unit operations are typically performed in separate rooms on separate days, work-in-process inventory consumes significant floor space and creates inefficient double handling, and off-line quality tests create bottlenecks and place completed product at risk.
Continuous processing, conversely, allows agile development on manufacturing scale systems, creating opportunities for rapid clinical development of breakthrough therapies, as well as the development of wider dosage ranges without extensive changes to the process. The compact nature of continuous OSD process equipment creates opportunities to modularize platforms and rapidly increase production in the face of drug shortages, in the specific geographic locations where these shortages exist. The PCMM (Portable, Continuous, Miniature and Modular) collaboration among Pfizer, GEA, and G-CON Manufacturing (GSK recently joined this alliance, as well) is the best example of the flexibility made possible through continuous OSD manufacturing, which was historically unattainable in conventional batch systems.
Despite these crucial advantages, the opportunity to improve quality is arguably the most compelling driver behind the agency’s relentless promotion of continuous manufacturing. The FDA’s vision is a pharmaceutical industry that consists of processes built on Quality by Design (QbD) methodology, utilizing integral Process Analytical Technology (PAT) and in-process control to deliver uniformly high quality product with minimal waste, and a reduced need for regulatory oversight and end product testing, with the ultimate goal of Real Time Release Testing (RTRT).
This look into the past is by no means intended to diminish the agency’s most recent efforts to promote continuous manufacturing. In December of 2015, the FDA Center for Drug Evaluation and Research (CDER) formed the Emerging Technology Team (ETT), intended to streamline submissions from drug companies seeking approval of products manufactured using an emerging manufacturing technology, such as continuous processing. In October of 2015, the FDA awarded $4.9 million in grants to The Center for Structured Organic Particulate Systems (C-SOPS), headquartered at Rutgers University, to focus on research aimed at advancing real-time methods to monitor and adjust continuous manufacturing systems in response to raw material variability, and support the development of regulatory science for continuous manufacturing of strip-film based drug-dosage forms capable of real-time release. If their 20-year track record is any indication, we should expect the FDA to continue to take bold initiatives to accelerate market adoption of continuous OSD manufacturing.