BeiGene adopts GE ‘turnkey’ factory for anti-PD-1 mAb production
BeiGene said it would adopt the KUBio factory to increase large-scale production of its immune-oncology therapies, including investigational anti-PD-1 monoclonal antibody (mAb), tislelizumab.
“Once approved, our commercial mAb products will [also] be manufactured there,” BeiGene spokesperson Liza Heapes told us.
KUBio is a pre-engineered facility designed around GE technology, such as the firm’s single-use biomanufacturing facility, FlexFactory. The current good manufacturing practice (cGMP)-compliant, modular construction can be built in approximately 18 months, and according to GE, can yield higher productivity by increasing the number of lots manufactured.
The first phase of the facility, located in the Ghangzhou region, is expected to be completed and operational by the end of next year.
GE in China
BeiGene is familiar with GE Healthcare’s bioprocessing range, having adopted the company’s FlexFactory platform for its Suzhou mAb plant in 2015.
GE Healthcare has co-developed a number of biopharmaceutical sites in China, including Pfizer, JHL, Cellular Biomedicine Group (CBMG) and Clover Biopharmaceuticals, however according to GE’s manager of BioProcess, Olivier Loeillot, the firm continues to focus on the global market.
“We are operating and collaborating with biopharmaceutical companies globally. The Chinese market is growing fast and therefore we are seeing many KUBio and FlexFactory installations in China,” he said.