The plant will focus on late-stage clinical therapeutic monoclonal antibodies (mAbs), and in particular United candidate HIV treatment UB-421. The Phase II candidate is primarily intended for treatment of HIV infected patients experiencing HIV viremia, and not responding to other anti-retroviral drugs.
According to GE Healthcare, the Taiwanese government is supporting the project to improve access to biopharmaceuticals and develop the bioprocess market in the region.
Taiwan’s Ministry of Economic Affairs said, “We expect that the successful operation of this plant will further enhance global competitiveness of Taiwan’s protein drug industry.”
UBP said it will initially focus on the local Taiwanese market, before entering global markets.
FlexFactory
GE Healthcare’s FlexFactory is a centrally automated, flexible bio manufacturing platform. It is primarily comprised of single-use technologies and associated process hardware.
USB Chairperson Dr. Chian Yi Wang said the technology will address capacity issues, explaining "two of GE’s 2,000 liter single-use bioreactors and integrated manufacturing process…resolves the manufacturing bottleneck for UBP’s rich pipeline.”
GE Healthcare told BioPharma-Reporter the overall project timeline for setting up a FlexFactory is between nine and 12 months, compared to up to 24 months when installing a stainless steel production platform.
“This means that the single-use technologies can help to reduce build costs up to 50 percent compared with equivalent traditional steel facilities,” said Sven Henrichwark, General Manager of GE Healthcare Life Sciences’ Global Commercial BioProcess department.
He added that: “FlexFactory…brings simplicity to the process. It reduces cost and risk compared with constructing a conventional fixed biotherapeutic manufacturing line.”
GE Healthcare cited other benefits, such as reduced cleaning procedures, which can result in diminished carbon dioxide emissions, water and energy consumption.
GE Healthcare did not disclose the sale price.
Other firms to have installed the FlexFactory platform include Beigene, JHL Biotech and Nanotherapeutics.