QbD Biotech Pilot Ready for Participants, FDA Seeks Volunteers

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

The program will aid FDA review of QbD approaches for biotechnology manufacturing, the agency said. Based on its experience with the program, 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 would enable drugmakers to make manufacturing process changes without having to submit postapproval manufacturing supplements.

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

The project will 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.