- China-based BeiGene has picked up an 'off-the-shelf' biologics manufacturing plant from GE Healthcare to build its cancer monoclonal antibodies output. BeiGene has three late-stage and five early-stage clinical assets in its pipeline.
- The prefabricated plant is part of GE Healthcare's KUBio business and incorporates the company's FlexFactory biomanufacturing. It will be situated in Guangdong Province, China, with the first phase operational in 2019.
- GE says its KUBio facilities can be ready to produce vaccines and monoclonal antibodies to current good manufacturing practice (cGMP) standards in 18 months, up to 50% faster than traditional manufacturing facilities.
Like many Asian drugmakers, BeiGene has spent hundreds of millions of dollars to expand its business and place on the world stage. That's not the easiest task either, given that continued safety violations have marred the image of pharma manufacturing quality in countries like China and India.
Beigene's therapeutic focus is cancer, with particular attention on oral small molecule drugs and immuno-oncology treatments like tislelizumab and BGB-A333, both of which target PD-1. It's one of several biotechs leading China's push into developing more novel drugs.
Snagging a production facility from an industrial giant could therefore further BeiGene's efforts.
"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," Jonathan Liu, senior vice president of biomanufacturing and head of biologics at BeiGene, said in a Sept. 17 statement.
"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," he added.
The relationship between GE Healthcare and BeiGene isn't a new one. The Chinese company is already using GE Healthcare's FlexFactory integrated biomanufacturing platform and single-use technologies to manufacture monoclonal antibodies for clinical trials at an existing manufacturing plant in Suzhou, China.
More broadly, GE Healthcare has already installed three KUBio facilities across China and more than 50 FlexFactories worldwide. The company touts that building the KUBio sites is 25-50% more cost-effective than comparable drug manufacturing plants. Another four KUBio facilities are currently planned for the GE BioPark in Cork, Ireland.