Month: March 2025

Why Do Some Biologics Cross the Finish Line—While Others Crash and Burn?

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Reading time: 4 minutes Share this article:   Imagine spending years and millions developing a groundbreaking biologic, only to see everything fall apart right at the doorstep of FDA approval. Frustrating, right? Unfortunately, it’s common—and often boils down to one overlooked area: Chemistry, Manufacturing, and Controls (CMC). So why exactly do promising biologics get derailed …