biospectrumasiaSeptember 19, 2018
BeiGene, Ltd., 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. 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.
GE Healthcare’s KUBio can be constructed, assembled and fully fitted-out to current Good Manufacturing Practices (cGMP) standards in approximately 18 months, which is up to 50 percent faster than traditional manufacturing facilities that usually require approximately three years before they are fully commissioned and qualified.
The facility is based on the single-use technologies that bring flexibility and are designed to yield higher productivity by increasing the number of lots manufactured, reducing maintenance requirements and shortening downtime between batches and products. GE Healthcare Life Sciences has delivered three KUBios to China and over 50 FlexFactories globally.
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