The new facility was built for JHL by GE Healthcare and subcontractor M+W Group in Stuttgart, Germany using GE's modular Kubio technology before being shipped to Wuhan for assembly.
It consists of prebuilt modules containing waste treatment facilities and clean rooms within a 2,400m2 floor space. Single-use bioreactors and chromatography equipment was shipped to Wuhan at the end of last year.
The facility will produce JHL’s candidate monoclonal antibodies (mAbs) for late stage trials and commercial supply. It will also be the base of cell line and process development activities and is expected to be validated in June.
UK biosim trial
Completion of the facility comes two weeks after the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted approval for a Phase I trial of JHL’s most advanced biosimilar candidate, JHL1101,
The trial – which is expected to start this year – is designed to establish JHL1101’s pharmacokinetic and pharmacodynamic similarity to Roche’s MabThera (rituximab), which is known as Rituxan in the US, Canada and Japan.
Supplies of JHL1101 for the Phase I study will be manufactured at JHL’s facility in Hsinchu, Taiwan, which also house processing equipment supplied by GE Healthcare.
If the drug progresses to late Phase trials production is likely to switch to the Wuhan facility, which is also likely to support commercial production should the biosimilar be approved.
JHL also intends to offer use of the Wuhan facility to its contract manufacturing customers and has previously spoken about offering it to the Chinese Government in the event of a pandemic.