WuXi Biologics provides comprehensive CMC development and GMP manufacturing services for a wide range of biologics and vaccines produced from microbial-based production systems as well as critical raw materials (e.g., enzymes, protein reagents) that are used in various applications. As a world-leading Contract Research, Development and Manufacturing Organization (CRDMO), we have built world-class facilities and established a highly-trained team of experts to provide end-to-end services from strain development to regulatory filing and beyond. All CMC and GMP activities for microbial fermentation-derived products are centralized at a dedicated site in Hangzhou, China. As all related services are provided at one geographic region and together with our highly efficient project management systems, we are able to greatly expedite product development and resource provisions.
Our centralized microbial platform site at Hangzhou, China is located just 15 km from Xiaoshan International Airport (Hangzhou), or 160 km from most regions in Shanghai (2 hours by car or 1 hour by high-speed train from Pudong International Airport).
Extensive Experience and Talented Team
WuXi Biologics has established technical leadership teams that have a wealth of industrial experience. We understand that expertise is paramount for the development of any microbial-derived product. Our highly educated staff is comprised of approximately 15% Ph.D. degree holders, and 55% M.S. degree holders. In addition, the Hangzhou region provides excellent access to a pool of scientific talent.
Comprehensive Range of Supported Product Modalities
We support an array of microbial fermentation products which includes plasmid DNA, enzymes, virus-like particles (VLP), antibody fragments, and other recombinant proteins. Our integrated service offerings included comprehensive strain development, process development, analytical, formulation, and drug product development, a Drug Substance (DS) GMP manufacturing facility with up to 2,000L scale fermenter, and a state-of-the-art robotic aseptic filling systems for Drug Product (DP) manufacturing.