WuXi Biologics recently announced that its Drug Substance (DS) and Drug Product (DP) manufacturing facilities at the Wuxi Mashan site has passed a 2-week Good Manufacturing Practice (GMP) inspection conducted by the US Food and Drug Administration (FDA). The inspection further strengthens the company's capabilities to ensure the reliable supply of its partners' commercial products to the US market.

The unannounced FDA GMP inspection covered multiple FDA-approved products, including monoclonal antibodies, bispecific antibodies, fusion proteins, and enzyme products. The successful completion of this routine FDA GMP inspection demonstrates WuXi Biologics' strict adherence to FDA GMP requirements, further reinforcing the company's regulatory compliance track record and underscoring its robust and reliable quality system, proven GMP operational excellence, and integrated capabilities to support global commercial manufacturing and supply.

The company’s Wuxi Mashan site was the first biopharmaceutical manufacturing facility in China approved by both the FDA and the European Medicines Agency (EMA) 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.

Dr. Chris Chen, CEO, WuXi Biologics, commented, "The successful completion of this FDA GMP inspection reaffirms our commitment to the highest standards of quality and operational excellence. Quality remains one of our key competitive strengths and a cornerstone of the trust our global partners place in us. As global demand for commercial supply continues to grow and regulatory expectations continue to rise, we remain dedicated to providing our partners with reliable, high-quality manufacturing services through our robust quality system, global manufacturing network, and expanding commercial capabilities. Through these efforts, we help our global partners bring innovative therapies to patients worldwide faster, more reliably, and at greater scale."