Seamless Onshoring From China-Based CDMO

Mitigating manufacturing risk in a challenging geopolitical landscape is a critical strategic imperative for biotech sponsors. When a U.S. company needed to rapidly onshore its clinical-stage monoclonal antibody program to ensure supply continuity and comply with emerging regulatory acts, success depended entirely on a seamless technology transfer.

Learn how a complex, large-scale (2,000L) manufacturing process was successfully relocated and qualified in just eight months. Achieving comparability with the original batch and ensuring an on-time release required a rigorous, cross-functional approach to analytical and process transfer. A structured framework, emphasizing early engagement, not only de-risked the program from geopolitical exposure but also provided the sponsor with enhanced speed, security, and full quality control.