CMC And Quality Considerations When Engaging Your CDMO

By Bikash Chatterjee, CEO, Pharmatech Associates

Identifying the right CDMO partner can be a complex undertaking, but lack of structure can lead to mistakes and lost development time. Before pursuing an outsourcing strategy, it is essential to define what processes will be kept in-house and where your CDMO partner will take the lead. This partner can be used to either spearhead or support several areas in the drug development road map, from the earliest stages in drug development through process characterization, tech transfer, and analytical method development to post-approval clinical commitments.

Understanding that a drug sponsor’s requirements for a CDMO partner will change as a product moves through its clinical program toward commercial manufacturing is fundamental when evaluating a CDMO’s ability to support your program. How a CDMO addresses two critical areas — CMC support and quality assurance — can often dictate how effective a CDMO can be in supporting and accelerating the timeline for the drug sponsor’s drug development program through commercial manufacturing.