Day: February 23, 2026
Biotech
Pharmaceutical
Regulation
Top CMC Pitfalls in Biologics IND Application and How to Avoid Them
Filing an Investigational New Drug (IND) application for a biologic—be it a monoclonal antibody, recombinant protein, or vaccine—is a high-stakes milestone. While the Chemistry, Manufacturing, and Controls (CMC) section is critical, many applications face delays due...