BeiGene, a commercial-stage biotechnology company focused on developing and commercialising 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.
“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,” said Dr Jonathan Liu, Senior VP, Biomanufacturing and Head of Biologics of BeiGene.
“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.
GE Healthcare’s KUBio can be constructed, assembled and fully fitted-out to current good manufacturing practice (cGMP) standards in approximately 18 months, which is up to 50% faster than traditional manufacturing facilities that usually require approximately 3 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 more than 50 FlexFactories globally.