Like traditional biologics, cell and gene therapies (CGTs) must meet safety and efficacy standards before they can be administered to human patients. But the manufacturing processes used for this new ...

The European Medicines Agency (EMA) released a final guideline on real time release testing (RTRT), aiming to provide better guidance for regulatory professionals to ensure their products consistently ...

Bulk harvest release testing for adventitious viruses is an integral part of biosafety for manufacturing biopharma products. Finding a testing strategy that works for diverse biologics modalities ...