WuXi Biologics operates multiple world-class GMP manufacturing facilities for the production of biologics around the world. Utilizing mammalian cell culture (e.g., CHO, NS0, HEK), and featuring our industry-leading WuXiaTM cell line development platform, we are able to produce a wide variety of biologics including monoclonal, bispecific and multispecific antibodies, fusion proteins, antibody drug conjugates, enzymes and other recombinant proteins. Over 260,000 L of bioreactor capacity is available by the close of 2022 for both clinical trials and commercial drug substance (DS) supply, increasing to 580,000 L across five countries by 2026. Clinical and commercial scale drug product GMP manufacturing is also available.
Implementing next-generation facility designs for multi-product facilities, a “scale-out” single-use bioreactor production scheme and continuous bioprocessing technologies, WuXi Biologics has become a leading global biologics supplier for our partners and clients. The success of our GMP operations is also due to our concept to commercialization drug development platform and excellence in project execution (see “The WuXi Biologics Difference” short videos for more information).
To support scale-up development efforts and large-scale process or batch record verification/qualification activities, both Wuxi and Shanghai sites maintain pilot/non-GMP manufacturing facilities with combined capacity of 11 x 50 L, 1 x 100 L, 14 x 200 L and 2 x 500 L single-use/disposable bioreactors. The manufacturing runs conducted at these sites also provide drug supply for IND-enabling toxicology studies or other preclinical and CMC development activities.
Each WuXi Biologics manufacturing facility shares the same quality system, and each site maintains dedicated in-house supporting functions such as QC testing labs, GMP warehouse, bio-waste and wastewater treatment, utilities (e.g., HVAC, WFI, Clean Steam, etc.), process automation systems (e.g., Delta V + OSI Pi Historian) and two independent power lines and back-up diesel generators. Click on the individual tabs below to learn more about each facility.