JHL Biotech Installs GE Healthcare's FlexFactory Biomanufacturing Platform
The flexible biomanufacturing system uses single-use technology.
GE Healthcare has completed installation of its FlexFactory biomanufacturing platform at JHL Biotech’s Research Center and manufacturing plant in Hsinchu, Taiwan, the companies announced in a press release. The new manufacturing platform will follow cGMPs 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 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, which allows manufacturers to rapidly respond to local healthcare needs. 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 preclinical and early-stage clinical work. In addition, it will serve as a proving ground for JHL Biotech for technology transfer. GE Healthcare’s 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.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
