A sponsored article from BioPharma Dive, written by Thermo Fisher Scientific's Kevin Kane, addresses the question of when to bring a CDMO into drug development. The piece argues that engaging early is useful, but that early engagement should not be confused with early commitment to specific manufacturing decisions.
The article recounts a biotech that moved quickly to produce an engineering batch using a solubility-enhancement approach for a poorly soluble API, based on a preliminary target product profile. After later PK and toxicology studies showed that much lower doses without solubility enhancement would suffice, the CMC work had to be repeated, delaying the IND and trial start.
Kane suggests distinguishing between CMC activities that can proceed with confidence and decisions that depend on clinical or nonclinical evidence still being generated. He cites a program where an injectable API used fit-for-purpose clinical supply for first-in-human studies, deferring process and scale development until safety and tolerability were confirmed, which supported an earlier IND submission.
The overall message is that optimizing CMC in isolation is not the goal; CMC should stay aligned with the broader development program, with ongoing communication across CMC, clinical, nonclinical, and regulatory teams. A faster CMC timeline does not accelerate development if new evidence forces the work to be redone.