The new manufacturing platform will follow current good manufacturing practices (cGMP) and be fully operational by the end of 2013. 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 quickly and easily establish biopharmaceutical manufacturing capacity within an existing building or as part of a new facility. Designed to help manufacturers such as JHL Biotech to rapidly respond to local healthcare needs and to support global customers in bringing lifesaving treatments to market more quickly, FlexFactory is comprised of single-use technologies and associated process hardware as well as all necessary automation and control components for start-to-finish manufacturing of biopharmaceuticals.
JHL Biotech’s 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 JHL Biotech for technology transfer. GE Healthcare’s experienced Shanghai Fast Trak team will validate equipment at the site and will train local JHL Biotech staff.
JHL Biotech’s facility includes two 500L single-use bioreactors, with the option to expand to four if greater throughput is required. FlexFactory 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, commented, “Our offering of tools, technologies and services for biomanufacturing has strength in both breadth and depth. For JHL Biotech we have been able to take an approach which recognises the differing requirements of multiple sites, whilst 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.”
Racho Jordanov, Co-founder, President and CEO of JHL Biotech, added, “JHL Biotech will make world-class biopharmaceuticals affordable to more people by utilizing innovations such as FlexFactory. Our biomanufacturing capability increases with the installation of cGMP manufacturing in our Taiwan facility. Because our biomanufacturing capabilities are shared across our facilities in Asia, we give our partners a unique offering.”