Seamless Onshoring from China-based CDMO to Avid Bioservices

Amid rising geopolitical tensions and the implications of the BIOSECURE Act, a U.S.-based biotechnology company made the strategic decision to relocate its monoclonal antibody manufacturing program from a China-based CDMO to a domestic partner. The molecule, in Phase 1 clinical trials, had previously been produced at a 2,000L scale in China. The sponsor sought a seamless transition to ensure regulatory compliance, supply continuity, and future commercial readiness.

This success story highlights how Avid Bioservices enabled a complete process and analytical transfer, culminating in CGMP manufacturing—all without disrupting development timelines. Within just eight months, Avid produced CGMP material using a 2,000L single-use bioreactor system, achieving strong comparability to the original batches. Their cross-functional technology transfer framework ensured rapid onboarding, regulatory alignment, and consistent product quality. The result was uninterrupted clinical trial supply, de-risked geopolitical exposure, and strengthened sponsor confidence.