Early CDMO engagement: balancing speed with flexibility in CMC planning

Bringing a new therapy to the clinic requires clinical, non‑clinical, regulatory and CMC activities to move forward together. In early development, having drug material available is often on the critical path to toxicology studies and first‑in‑human trials, which creates pressure to involve a contract development and manufacturing organization (CDMO) early.

However, starting CMC work early does not mean committing to a fixed plan. Choices about indication, dose, formulation, route of administration, non‑clinical studies and trial design all shape what the CMC program ultimately needs. When these workstreams are planned in isolation, CMC decisions can outpace the evidence needed to support them, leading to rework that wastes time and money.

A biotech company developing a poorly soluble active ingredient experienced this first‑hand. Early assumptions about the API’s properties changed as more data emerged, requiring the CDMO to revisit earlier work and adjust the manufacturing approach. The case highlights the importance of keeping CMC decisions flexible while still advancing critical activities early.