CAR-T Manufacturing: Guidance Anticipates Platform Challenges And Opportunities
Draft from US FDA advises sponsors on how to draw from platform knowledge, while anticipating issues associated with emerging centralized and distributed manufacturing approaches for autologous and allogeneic products and their viral vectors.
You may also be interested in...
Final gene therapy IND CMC guidance clarifies expectations on process evolution, distinguishing drug substances from products, cGMP oversight and more.
Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.
All-out efforts by agency staff to help industry supply COVID-19 treatments last year were applauded but now its attention returns to the top pre-pandemic priority, contamination risks. Edge Pharma consents to attack mold, Glicerinas blocked over inspection refusal, Bioiberica hit for ‘reprocessing’ contaminated drug substance, Rentschler bashed for inadequate monitoring.