Bion Labs is a peptide-only technical partner for early-stage biotech. Pre-CDMO decision architecture, risk mapping, and CDMO qualification governance.
Two-week written diagnostic of a peptide program's pre-CDMO position. Fixed scope, fixed cost. Founder-led, peptide-only.
Five documented deliverables in 3 to 5 weeks: Risk Mapping Matrix (RPN), Decision Architecture Map, CDMO Capability Envelope, Specification Gap Map, Executive Technical Summary.
Explicit scope boundaries for pre-CDMO peptide CMC work. Pre-CDMO Decision Architecture, Risk Mapping, CDMO Qualification Logic, Specification Gap Assessment, Tech Transfer Readiness Review.
Structured workflow from initial contact through Tier A deliverables and optional Tier B governance during active CDMO execution.
The decision is the risk problem. Most peptide programs fail because of decisions made before the CDMO SOW is signed.
Seed to Series A biotech with 1 to 2 synthetic peptide programs, 4 to 12 weeks before CDMO SOW signature.
Not for non-peptide modalities, active GMP manufacturing without governance gaps, or CDMO brokerage requests.
Evaluate process definition, analytical methods, documentation, and tech transfer preparedness before CDMO engagement.
Structured CDMO qualification framework. Capability envelope assessment covering synthesis, purification, analytical methods, and GMP track record.