Biotech QbD Encounters Uncertainties Over Definitions and Regulatory Relief
This article was originally published in The Gold Sheet
As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.
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Ways to assess criticality of MAb quality attributes explored by FDA and industry biotech QbD experts. FDA official suggests borrowing from ICH Q5E guideline for biologics comparability. This could be particularly useful for distinguishing impurities from variants. Biotech experts agree that risk filtering is the best risk assessment method for this task. Medimmune uses risk filtering to show why FDA can safely ignore glycosylation for one compound. A suggestion that companies share platform knowledge could radically alter playing field, given that most applicants lack such platforms. Conformia goes bankrupt but its mock antibody lives on. CMC strategy forum to explore QbD risk assessment process in context of production bioreactor.
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.
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.