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BeiGene is set to build late-stage clinical and commercial production capacity for cancer monoclonal antibodies with GE Healthcare’s KUBio, the prefabricated biopharma facility based on single-use technologies.
On Sept. 18, 2018, BeiGene, a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, has selected GE Healthcare Life Sciences’ off-the-shelf biomanufacturing facility, KUBio, for large-scale production of its cancer monoclonal antibodies (mAbs).
The KUBio will be located in Guangzhou, the capital city of Guangdong Province, China, where an increasing number of biotech firms are establishing operations, GE reports. The first phase of the facility is expected to be completed and operational in 2019. BeiGene is already using GE Healthcare’s FlexFactory, an integrated biomanufacturing platform in its existing manufacturing plant in Suzhou, China, to manufacture mAbs for clinical trials.
“To realize our mission of developing innovative solutions to help cancer patients in China and globally, BeiGene is constantly focused on quality and agility, not only in R&D, but also in manufacturing,” said Jonathan Liu, PhD, senior vice president, biomanufacturing and head of biologics at BeiGene, in a company press release. “We believe that the implementation of the KUBio facility will help us to produce antibody-based medicines with a high standard of quality to address the unmet and urgent needs of cancer patients.”
“BeiGene is one of the leading biotechnology companies from China, striving to serve patients with new cancer therapies worldwide. We believe that KUBio will help BeiGene to reach the China and global markets more quickly, using a flexible and reliable manufacturing platform that meets the highest regulatory standards,” said Olivier Loeillot, general manager, BioProcess, GE Healthcare Life Sciences, in the release.
GE Healthcare states that the KUBio can be constructed, assembled, and fully fitted-out to current cGMP standards in approximately 18 months. The facility is based on the single-use technologies designed to yield higher productivity by increasing the number of lots manufactured, reducing maintenance requirements, and shortening downtime between batches and products. GE Healthcare has delivered three KUBios to China and over 50 FlexFactories globally.
Source: GE Healthcare