New Ways to Ascertain Critical Attributes of Monoclonal Antibodies Explored
This article was originally published in The Gold Sheet
Executive Summary
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.