The necessity of FDA reviewers and auditors to possess comprehensive knowledge of the manufacturing process is vital to pharmaceutical approvals with all manufacturing processes being verified and validated. The emergence of gene therapy, cell therapy, advanced automation, and other bioprocess innovations poses potential challenges for FDA personnel who must keep abreast of industry innovations.
The solution is to optimize biopharmaceutical manufacturing process-related training resources for FDA reviewers and auditors – with a focal point being new complexities introduced by gene therapy, cell therapy, advanced automation, and other bioprocess innovations. Advancing the manufacturing knowledge to federal agencies such as the FDA can reduce approval time of new biopharmaceuticals. This will also allow the FDA the opportunity to verify and pinpoint possible areas in the manufacturing process that can affect the safety and efficacy of a product. Being able to find possible pitfalls in the process earlier with a more educated regulatory workforce can accelerate the manufacturing process and decrease lag time for process approvals of new biopharmaceutical products.
Identification of potential in advanced cell and gene therapy manufacturing training for the regulatory workforce
Assessment of existing training opportunities and identification of gaps and unmet needs in regulator training opportunities
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University of Maryland College Park
North Carolina State University
