CMC And Quality Considerations When Engaging Your CDMO

By Bikash Chatterjee, president and CSO of Pharmatech Associates, a USP Company and USP Microbiology

Deciding to use a CDMO to support your drug development program adds complexity and risk if the right partner is not identified and engaged. 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.