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news.GE said that global biotech company BeiGene has selected KUBio, GE Healthcare Life Sciences’ off-the-shelf biomanufacturing facility, to increase its manufacturing capacity for cancer drugs.
Image: GE KUBio biomanufacturing facility for BeiGene. Photo: courtesy of General Electric.
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The KUBio biomanufacturing facility for BeiGene will be located in Guangzhou in the Chinese province Guangdong, where other biotech firms are setting up operations, said GE.
It will be used for producing the biotech company’s cancer monoclonal antibodies (mAbs) on a large scale.
The first phase of the KUBio facility is slated to be completed and operational next.
GE Healthcare Life Sciences bioprocess general manager Olivier Loeillot said: “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.”
According to GE, KUBio biomanufacturing facility can be built, assembled and fitted-out fully to comply with current Good Manufacturing Practices (cGMP) standards in nearly 18 months. This, the US conglomerate claims is up to 50% faster than conventional manufacturing facilities that otherwise normally need about three years before getting fully commissioned and qualified.
KUBio is based on the single-use technologies that add flexibility and are designed to produce higher productivity by increasing the number of lots manufactured, said GE. The GE biomanufacturing facility is also claimed to lower maintenance requirements and shorten downtime between batches and products.
BeiGene biomanufacturing senior vice president and biologics head Jonathan Liu said: “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.
“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 already utilizing GE Healthcare’s FlexFactory, which is an integrated biomanufacturing platform. The FlexFactory for the biotech company, which is located in its existing manufacturing plant in Suzhou, China, manufactures mAbs for clinical trials.
