Will use 100% disposable equipment for manufacturing biologics
WuXi AppTec has officially opened its cGMP biologics manufacturing plant in WuXi, China. The firm claims the facility is the first in China to meet US, European and Chinese GMP standards, and the first in the world to use completely disposable equipment for manufacturing biologics.
‘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 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.’
WuXi AppTec offers an 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 agreed three biologics deals including a collaboration with Open Monoclonal Technology will use OmniRat, the first fully human monoclonal antibody platform based on transgenic rats, to develop novel human antibodies for global clients.
The second is a contract with TaiMed Biologics to produce the HIV compound ibalizumab for global Phase II and III clinical trials; while the third is 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.
Martin Mackay, president of R&D at AstraZeneca, said the joint venture with WuXi would allow both companies to bring benefit to patients.
‘No single company has all the solutions to the healthcare challenges of today,’ he said. ‘That's why collaborations such as our joint venture with WuXi AppTec are so important. Our mutual ambition is greatly to increase the number of people who ultimately benefit from our medicines.’