Biopharmaceutical Manufacturing for the FDA

The project team will evaluate existing training facilities, existing FDA training programs, as well as input from FDA and industry to 1) identify training gaps and 2) develop a plan for aligning training resources and developing curriculum.

Project status

100% Completed

Industry Need

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.

Solution

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.

Outputs/Deliverables

The team held phone calls with FDA and industry contacts and sent out surveys to identify potential training program needs.
An open dialogue was formed between the FDA and training stakeholders into the needs and interests of how training in new biomanufacturing technologies should occur for investigators.
Surveys were completed by industry.
An informal list of suggested training methods and needs for FDA was developed.

Impacts

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

Additional Project Information (Members Only)

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Project Lead

University of Maryland College Park

Participating Organizations

North Carolina State University