The market for Advanced Therapies has come a long way in the last decade, to the point that some cell and gene therapies have already been approved, and others have now entered the later stages of development – reflected in a shift towards later clinical trials. Inevitably this is resulting in more formal requirements for manufacturing process consistency, GMP standards and so on. Elena Meurer at Biopharma Excellence discusses the manufacturing and quality implications of novel biopharma treatments.