WuXi cuts ribbon on biologics plant

pharmafile | October 23, 2012 | News story | Manufacturing and Production CGMP, WuXi AppTec 

China’s WuXi AppTec has officially opened a new biologics manufacturing facility that forms the centrepiece of the company’s recently-signed alliance with AstraZeneca.

The plant in Wuxi, Jiangsu province, is said to be the first plant in China that complies fully with current Good Manufacturing Practice (cGMP) standards in the US and EU, and is also the first to make 100% use of disposable equipment for manufacturing biologics drug substances.

Speaking at the opening, WuXi AppTec’s chairman and chief executive Ge Li said the facility will allow the company to provide “world-class services for anyone conducting research in biologics discovery, development and manufacturing, including multinational and Chinese pharmaceutical and biotech companies”.

One of the main clients for the plant from the outset is AstraZeneca, whose Medimmune subsidiary formed a joint venture with WuXi AppTec earlier this year to bring an autoimmune and inflammatory disease drug candidate – interleukin-6 inhibitor MEDI5117 – to the Chinese market.

AstraZeneca R&D president Martin Mackay attended the opening of the facility and a monoclonal antibody conference organised by WuXi AppTec, and said the alliance will help both companies bring benefit to patients.

AZ has its own plants in China – including a 96,000 sq. m. production facility and packaging unit in WuXi and last year announced plans to build a $200m facility for intravenous medicines in Taizhou, that is due to come on line in 2013.

However: “No single company has all the solutions to the healthcare challenges of today,” said Mackay, adding: “That’s why collaborations such as our joint venture with WuXi AppTec are so important.”

Other deals recently signed by WuXi AppTec in the biologics field include a contract with TaiMed Biologics to produce the HIV compound ibalizumab for global Phase II and III clinical trials, as well as a deal with US firm Open Monoclonal Technology to use its transgenic OmniRat platform to develop fully human monoclonal antibodies for clients.

Phil Taylor

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