Biotech QbD Pilot to Explore ‘Expanded Change Protocols'
This article was originally published in The Gold Sheet
Executive Summary
Quality-by-design and risk management for biotech products will be explored in an FDA pilot program modeled after agency’s small-molecule CMC review pilot. New program will address not just biotech NDAs and BLAs but also manufacturing supplements using new ‘expanded change protocols.’ FDA seeks diverse array of pilots, including proposals for monoclonal antibody platforms, protein therapeutics, compliance-related issues, and novel approaches to linking attributes to safety and efficacy. Acceptance criteria discussed. Limited to 15 pilots.