When a catastrophic compliance failure derailed Veloxis’ relationship with its incumbent biologics CDMO, the team faced a critical challenge: find a new partner and recover the CMC timeline ahead of Phase 2 clinical trials. In just 6 months, Veloxis conducted an expedited CDMO search, selected Bionova, and executed contracts and a highly collaborative tech transfer and process development. The joint team advanced rapidly from lab-scale evaluations to a 200L pilot run that exceeded performance expectations, all within 6 months from go. This effort culminated in a manufacturing green light and minimizing the project delays. This talk will share the decision-making frameworks, risk mitigation strategies, and executional lessons from a real-world CMC crisis and recovery.