WuXi Biologics operates multiple state-of-the-art, world-class drug product (DP) manufacturing facilities for the formulation and fill of biotherapeutics and vaccines as well as liquid and lyophilized parenterals. We currently maintain 11 drug product facilities capable of conducting liquid or lyophilized fills at varying clinical and commercial scales and utilizing a variety of container and closure system (CCS) configurations that include vials, prefilled syringes and other combination product CCS.
All of our facilities provide isolator-based, fully-automated final drug product formulation and filling under Current Good Manufacturing Practice (cGMP) conditions as defined by the worldwide regulatory agencies, including the United States Food and Drug Administration (U.S. FDA), European Medicines Agency (EMA) and National Medical Products Association (NMPA). We have provided cGMP drug product for clinical and commercial use in a variety of countries and regions such as the US, EU, China, Japan, South Korea, Singapore, Australia, Israel and India.
The success of our GMP drug product operations is also due in part to our concept to commercialization drug development platform, extensive GMP drug substance manufacturing network, outstanding quality system and excellence in project execution (see “The WuXi Biologics Difference” short videos for more information). For details on each DP facility, click the corresponding links below.