WuXi Biologics (药明生物; WuXi Biologics (Cayman) Inc.) is a global contract research, development, and manufacturing organization (CRDMO) focused on biopharmaceuticals. The company provides end-to-end services covering cell line development, process and analytical development, technology transfer, and GMP manufacturing of drug substance and drug product, including sterile fill–finish for vials and pre-filled syringes. Its platforms support monoclonal antibodies and other recombinant protein therapeutics.
Headquartered in Wuxi, China and listed in Hong Kong, WuXi Biologics operates a network of GMP facilities across Asia, Europe, and North America, utilizing single-use and perfusion bioreactor technologies. The company applies Quality by Design principles, process analytical technologies, and integrated digital systems to enable scale-up and lifecycle management. WuXi Biologics serves global biopharmaceutical customers under multi-site quality systems with regulatory approvals from major health authorities such as the FDA, EMA, and China’s NMPA.
Also known as WuXi Biologics (Cayman) Inc. and 药明生物.
chemXplore tracks 3 projects involving WuXi.
WuXi's role on them: Owner, Investor / Financier, Operator, and Developer.
Passed a two-week unannounced FDA GMP inspection covering drug substance and drug product manufacturing, reinforcing U.S. commercial supply reliability.
Selling 51.1% stake in Bestchrom; deal expected by December 2026. Bestchrom supplies chromatography resins, columns and downstream process development services.
Trispecific ophthalmic antibody marks the platform's 1,000th molecule; collaboration advanced multiple multispecifics, fusion proteins and ADCs from DNA to IND with faster-than-average timelines.
FDA PLI pass enables commercial manufacture of a potential blockbuster autoimmune therapy; facility uses 12×4,000L single‑use bioreactors and 4,000–20,000L scale‑out capacity.
ANVISA certified three Wuxi facilities with zero findings, allowing end‑to‑end commercial manufacture and supply of an anti‑PD‑L1 cancer immunotherapy and support for Latin America entry.
MFG17 at Shanghai Fengxian finished first GMP production with zero deviations; 9,000 L single‑use capacity, 80–100 batches/year, multiple process modes and digitalized operations.
EMA found zero critical findings in a four-day GMP inspection supporting EU marketing authorization for 19 biologics from 13 clients.
Placed in S&P Global CSA Global Top 1% and included in both the Global and China Sustainability Yearbooks; company emphasises Green CRDMO solutions.
