FDA Launching QbD Biotech Pilot, Will Draft Guidance

The FDA is looking for companies to participate in a quality-by-design (QbD) pilot program intended to help the agency develop guidance on biotechnology submissions.

The program will help the FDA review QbD approaches for biotechnology manufacturing, the agency said. It follows the QbD small-molecule pilot program, which the agency regards as successful. Based on its experience with the biotech program and its prior knowledge, the FDA will work toward implementing a QbD, risk-based approach for complex products in addition to drafting guidance for industry.

QbD is a process that incorporates the principles of the International Conference on Harmonisation’s Q8, Q9 and Q10 guidelines, which cover aspects of improving pharmaceutical quality over a product’s life cycle.

Manufacturers can use QbD to convince the FDA to allow less end-product testing if substantial process and product knowledge is demonstrated. QbD might enable manufacturers to make certain manufacturing process changes without having to submit postapproval supplements.

Participants in the pilot program will submit quality information for their biotechnology products. Submissions will include BLAs, BLA supplements or NDAs reviewed by the Center for Drug Evaluation and Research’s Office of Biotechnology Products. Applicants need to demonstrate increased knowledge of product attributes, linking such attributes to process parameters in an expanded change protocol.

The project is supposed to explore the use of these protocols to describe the specific tests, studies and acceptance criteria that demonstrate certain manufacturing changes will not have adverse effects.

More information is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0355-n.pdf.