BeiGene to install GE’s FlexFactory for pilot cGMP production facility in China
Facility will manufacture biologics for clinical trials
GE Healthcare’s Life Sciences business has announced that BeiGene has selected GE’s FlexFactory biomanufacturing platform for its first current Good Manufacturing Practices (cGMP) biomanufacturing facility in Suzhou, China. Currently under construction, the facility is expected to be operational by 2017.
BeiGene is a clinical-stage biopharmaceutical company focused on discovering and developing innovative, molecularly-targeted and immuno-oncological drugs that address severe unmet medical needs in a variety of cancer indications. Announced in August 2015, the company’s new pilot-scale facility will manufacture monoclonal antibodies in its biologics pipeline for clinical trial use.
Predominantly based on single-use technologies, the integrated FlexFactory platform installed at the Suzhou facility will help Beigene to reduce the build-up and commissioning time and help to increase the speed to global markets, including the US, Europe and China, GE said.
Olivier Loeillot, General Manager, Commercial BioProcess Asia, GE Healthcare Life Sciences, said: 'BeiGene is an outstanding exponent of the new wave of exciting biopharma companies coming out of China. Their need to accelerate the development pathway and then reach the market quickly, coupled with a desire to meet global regulatory standards, is something GE is well-placed to support. Not just with the exceptional scalability and applicability of the FlexFactory, but also with all the accompanying support for validation, training, and service.'
John Oyler, Chief Executive of BeiGene, added: 'We’re excited to be working with GE in connection with our new pilot production facility as we seek to accelerate and expand our development programmes. GE’s FlexFactory gives us the speed, flexibility and quality that allows us to continue to focus on developing global, potentially best-in-class drugs for various cancer treatments.'