Most pharmaceutical manufacturers are adopting or making plans to adopt the continued process verification approach outlined in FDA’s November 2011 process validation guidance, which will shine a light on their manufacturing processes. But not everyone is anxious to see what that light will reveal.

The pharmaceutical industry is advancing ideas for estimating the number of batches to run during process validation as well as how to establish robust monitoring and testing programs for products on the market. Industry has been hammering out these details in the absence of many specifics in the FDA’s 2011 process validation guidance on these areas.

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.