Global contract research, development and manufacturing organization (CRDMO) WuXi Biologics announced that its drug substance (DS) and drug product (DP) manufacturing facilities at the company’s Wuxi Mashan site in China successfully passed a two-week GMP inspection conducted by the U.S. Food and Drug Administration.

The unannounced inspection covered multiple FDA-approved products including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzyme products, according to WuXi Biologics. Described as a routine inspection, the CRDMO said it reinforced the company’s regulatory compliance track record and underscored its “robust and reliable” quality system as well as demonstrated GMP operational excellence.

Over the past 13 years, WuXi Biologics claims its Wuxi Mashan site has achieved a 100% success rate in more than 600 regulatory and client audits and has supported the global launch of over 20 biologics. The company contends the Wuxi Mashan site was the first biopharmaceutical manufacturing facility in China approved by both the FDA and the European Medicines Agency for commercial production.

“By integrating DS and DP manufacturing capabilities within a single site and leveraging its end-to-end service platform, WuXi Biologics streamlines technology transfer, process scale-up, and commercial supply, accelerating project execution and enhancing supply chain efficiency,” according to the announcement.

Currently, WuXi Biologics operates 26 DS and 19 DP facilities as part of its global manufacturing network in China, Germany, Ireland, Singapore, and the U.S. Focused on a global “dual sourcing” strategy, the CRDMO is accelerating its production capacity expansion globally through continued investments and strategic asset acquisitions.