IPO ready BeiGene adopts GE tech for China cancer biologics plant
The Beijing-headquartered cancer drug firm said the GE system will “significantly reduce the build-up and commissioning time and help to increase the speed to global markets, including the United States, Europe and China.”
BeiGene started building the facility in August after securing a plot at the Suzhou Industrial Park an hour outside Shanghai.
At the time the firm said the facility will support both clinical trials and commercial production of its candidate cancer biologics when operational in 2017.
BeiGene's most advanced candidate is BGB-283 - an RAF dimer inhibitor of solid tumors – that entered a Phase I trial in October after showing promise in preclinical studies conducted by Wuxi AppTec and Joinn Laboratories.
BeiGene has also announced its intention to go public and list on the NASDAQ in the US.
BeiGene will use the Flexfactory system to culture cell lines developed using a platform licensed from SAFC, the custom manufacturing business of recent Merck acquisition Sigma Aldrich.
That deal – signed in March – granted BeiGene rights to develop monoclonal antibody (mAb) production cell lines using SAFC’s CHOZN platform.
The platform combines zinc finger nuclease (ZFN) gene editing and the glutamine synthetase CHO cell line that SAFC launched in 2011.
Speed was also a driver for the SAFC deal according to BeiGene’s biologics head Kang Li.
He said at the time “our objective in selecting SAFC’s CHOZN Platform and services was to shorten bioproduction times in early development and to obtain a manufacturing clone quickly with the highest protein quality specifications.”
Speedy set up
GE Healthcare acquired the FlexFactory system when it bought Xcellerex in 2012. Since then the General Electric division has sold the system to various drugmakers – including Patheon acquisition Gallus and China-based manufacturer JHL Biotech – and more recently Nanotherapeutics.
The firm welcomed BeiGene’s comments about set-up speed, telling us "the typical time to complete the installation of a FlexFactory is nine months. This includes a planning and design phase, construction and installation, and then validation. The key to compressing the timeline is working in parallel where possible. For example, the customer's initial acceptance testing of the single-use technologies that make up the FlexFactory begins at GE's sites in Marlborough and Uppsala, prior shipping to their own facility."
"The FlexFactory platform, which is comprised predominantly of single-use technologies, will incorporate a 500 L scale single-use bioreactor, the Xcellerex XDR 500, to meet BeiGene's pilot scale requirements. The platform comprises distinct unit operations connected via single-use tubing sets and is controlled by a centralized automation system."