CMO Validation As A Service

Robert Bagley from CAI played a pivotal role in the successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility during the 2022-2023 fiscal year. The project was completed on time and within budget, earning recognition as an ISPE Facility of the Year contender, which I believe it ultimately won.

Subsequently, the client issued a highly competitive RFP for CQV services on specialized equipment required for a specific campaign. CAI's innovative Validation as a Service (VaaS) model enabled us to submit a proposal that was approximately half the cost of competing bids, aligning with the client's tight budget and aggressive timeline dictated by the end customer.

The project encompassed the development of a comprehensive C&Q plan and the qualification of critical CG&T process equipment, including single-use bioreactors, freezers, incubators, a cold room, and floor centrifuges. The overarching goal was to ensure all equipment was qualified for a Phase 3 clinical production campaign commencing in September 2024.