WuXi AppTec has officially opened its new cGMP biologics manufacturing facility in WuXi. The firm marked the event by hosting the inaugural Global Monoclonal Antibody Summit. It claims the new facility is the first in China to meet U.S., European, and Chinese GMP standards, and is the first in the world to use 100% disposable equipment for manufacturing biologic drugs.
“The establishment of this cGMP biologics facility has greatly improved WuXi’s services in biologics manufacturing and further showcases our commitment to global clients,” comments Ge Li, Ph.D., chairman and CEO. “WuXi is determined to provide world-class services for anyone conducting research in biologics discovery, development, and manufacturing including multinational and Chinese pharmaceutical and biotech companies.”
WuXi AppTec offers a broad, integrated portfolio of laboratory and manufacturing services spanning discovery services, through to manufacturing for advanced intermediates and APIs, cell banking services, and cGMP manufacturing for cellular therapeutics and combination/tissue-based products. The firm recently announced a number of biologics agreements. A collaboration with Open Monoclonal Technology signed last month will exploit the latter’s transgenic rat OmniRat™ platform for the development of human antibodies for global clients. A contract with TaiMed Biologics signed in August is centered on production of the anti-HIV compound ibalizumab for global Phase II and III clinical trials. Also last month WuXi and AstraZeneca’s biologics subsidiary MedImmune established a joint-venture to develop MEDI5117, an IL-6 inhibitor for rheumatoid arthritis and autoimmune disorders, in China.