The CMC Trap: How Chemistry, Manufacturing, and Controls Failures Derail Drug Development

In the high-stakes environment of drug development, Chemistry, Manufacturing, and Controls (CMC) is too often viewed as a regulatory hurdle to clear rather than a core strategic function. This misperception has led to costly delays, clinical holds, and even outright refusals to file. In this white paper, we explore how the “CMC trap” continues to derail promising therapies and outline how organizations can shift their mindset to integrate CMC thinking early and intentionally.