Will be used for cell line development, process development, and cGMP manufacturing in pre-clinical and early-stage clinical work
GE Healthcare has completed the installation of its FlexFactory biomanufacturing facility at JHL Biotech’s Research Centre and manufacturing plant in Hsinchu, Taiwan.
The new facility will follow current good manufacturing practices (cGMP) and be fully operational by the end of this year. It is similar to the production process at JHL Biotech’s KUBio modular biopharmaceutical factory currently under construction by GE Healthcare at the Biolake Science Park in Wuhan, China.
GE Healthcare’s FlexFactory is a centrally automated, flexible biomanufacturing platform. It allows manufacturers to establish biopharmaceutical manufacturing capacity within an existing building or as part of a new facility.
Designed to help manufacturers rapidly respond to local healthcare needs and to support global customers in bringing treatments to market more quickly, FlexFactory comprises single-use technologies and associated process hardware as well as all necessary automation and control components for start-to-finish manufacturing of biopharmaceuticals.
The FlexFactory in Taiwan will be used for cell line development, process development, and cGMP manufacturing in pre-clinical and early-stage clinical work. In addition, it will serve as a 'proving ground' for technology transfer. GE Healthcare’s Shanghai Fast Trak team will validate equipment at the site and train local JHL Biotech staff.
Included in the facility are two 500L single-use bioreactors, with the option to expand to four if greater throughput is required. It enables JHL Biotech to develop manufacturing processes prior to launching full-scale manufacturing operations in its Taiwan facility and prior to its KUBio factory in Wuhan becoming fully operational in early 2015.
Olivier Loeillot, General Manager of Enterprise Solutions, GE Healthcare Life Sciences, said: 'For JHL Biotech we have been able to take an approach which recognises the differing requirements of multiple sites, while at the same time allowing them to replicate processes. FlexFactory is highly complementary to our KUBio offering, primarily aimed at those organisations repurposing or expanding an existing site.'