BeiGene Plans First cGMP Manufacturing Facility in Suzhou, China

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Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

BeiGene, a clinical-stage biopharmaceutical company based in Beijing and focused on developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced on Aug. 20, 2015 that it is establishing its first cGMP biopharmaceutical manufacturing facility for commercial use. The facility will be built at BioBAY in the Suzhou Industrial Park (SIP) in Suzhou, China.

The new, 9000-m2 (96,875-ft2) facility expands the company's production facilities and will supply materials for future clinical trials and subsequent commercial demand. The facility is expected to be completed by 2017.

"This new manufacturing facility is a key component to our strategic growth to become an integrated biopharma company and to accelerate and expand our development programs, which allows us to continue to focus on developing global best-in-class drugs for various cancer treatments and attract additional highly talented professionals to our organization," said John V. Oyler, BeiGene CEO, in a press release. "With a manufacturing site in BioBAY, we are well positioned to fully leverage the domestic regulatory pathway for our drugs in China and to build a global business."


“This will be a truly cutting-edge, state-of-the-art facility utilizing the leading technologies in biomanufacturing that will also meet the utmost regulatory standards,” said Wendy Yan, head of Regulatory Affairs, in the release. “Upon completion, we will seek the necessary approvals to ensure our new site is fully compliant with regulatory procedures in all key global markets, including the United States, Europe, and China.”

Source: BeiGene