WuXi AppTec, a pharmaceutical, biotechnology and medical device R&D outsourcing company, has opened a cGMP biologics facility in China.
The biologics manufacturing facility in Wuxi is the first in China to meet GMP standards of the U.S., the E.U. and China, marking another milestone for the company. This facility is also the first one globally to utilize 100% disposable equipment for biologics drug substance manufacturing.
"The establishment of this cGMP biologics facility has greatly improved WuXi's services in biologics manufacturing and further showcases our commitment to global clients," said Dr. Ge Li, chairman and CEO of WuXi AppTec. "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."
The company recently announced three deals in biologics: a collaboration with Open Monoclonal Technology to use OmniRat, the first fully human monoclonal antibody platform based on transgenic rats, to develop novel human antibodies for global clients; a contract with TaiMed Biologics to produce the HIV compound ibalizumab for global phase II and III clinical trials; and a joint venture agreement with MedImmune, the global biologics arm of AstraZeneca, to develop MEDI5117, an IL-6 inhibitor for rheumatoid arthritis and autoimmune disorders in China.
Dr. Martin Mackay, president of R&D at AstraZeneca, stressed that the joint venture with WuXi will help both companies bring benefit to patients.
"No single company has all the solutions to the healthcare challenges of today,” said Mackay. “That's why collaborations such as our joint venture with WuXi AppTec are so important. Our mutual ambition is to greatly increase the number of people who ultimately benefit from our medicines."