WuXi Biologics achieves GMP release of 18th drug product facility in Shanghai

WuXi Biologics, a contract research, development and manufacturing organization (CRDMO) headquartered in Shanghai, China, has achieved GMP release of its Drug Product Facility 15 (DP15) at its Fengxian site in Shanghai, bringing the company’s total operational drug product facilities to 18 globally.

The facility received GMP release in April and has since completed multiple engineering and GMP batches, delivering clinical supplies to support client regulatory filings and clinical development needs, according to the announcement. The site is equipped with isolator-based aseptic filling lines supporting both liquid and lyophilized drug product manufacturing, with capabilities including 100% fill weight check, nitrogen overlay, and low-temperature loading for lyophilization, the company said. The facility supports vial sizes ranging from 2R to 20R.

WuXi Biologics global network spans China, the United States, Ireland, Germany, and Singapore. In addition to the 18 drug product facilities, the company also operates 24 drug substance facilities. By the end of 2025, the company said it had delivered more than 2,350 drug substance batches and more than 2,260 drug product batches and passed 46 regulatory inspections worldwide with a 100% success rate and no critical findings.

The DP15 release follows WuXi Biologics’ receipt last month of GMP certification from South Korea’s Ministry of Food and Drug Safety for three facilities in Wuxi, China, covering drug substance manufacturing, fill-finish, and packaging for commercial-scale production of a bispecific antibody for biliary tract cancer, following a five-day inspection with no critical or major findings.