Xellera Therapeutics Launched Hong Kong’s First Commercial Current Good Manufacturing Practice (cGMP) Facility For Cell & Gene Therapy Products
For Cell and Gene Therapy Products
- Hong Kong’s first-of-its-kind >8,500 ft² commercial cGMP facilities for cell and gene therapy products at Hong Kong Science Park and Millennium City 5, supported by additional 15,000 ft² R&D and office space.
- Xellera is proud to be the industrial sponsor and partner of a grant awarded from the Innovation and Technology Commission (ITC) of Hong Kong SAR Government to support the collaborating team consisting of the Hong Kong Red Cross Blood Transfusion Service, Queen Mary Hospital, University of Hong Kong and Scottish National Blood Transfusion Service and University of Edinburgh to establish the first clinical-grade human induced pluripotent stem cell (iPSC) haplobank for Southern Chinese.
- Clinical-grade mesenchymal stem cells, and other gene & cell therapy products for various heart diseases, cancers, etc, are in the pipeline. Xellera is launching several clinical trials with details to be further announced.
Hong Kong, 8 February 2021 –
Xellera is pleased to announce the launch of Hong Kong’s first-of-its-kind commercial current Good Manufacturing Practice (cGMP) facilities for Cell and Gene Therapy Products (a.k.a. Advanced Therapy Medicinal Products or ATMP) at Hong Kong Science Park and Millennium City 5. Having invested over HK$150M to expand the capacity for such next-generation therapeutics, the construction of our cGMP facilities is now complete.
The brand-new state-of-the-art cGMP facilities of >8,500 ft2 follows the international standards, including those of the Department of Health of Hong Kong, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA), which are specific for the complex manufacturing process of cell and gene therapy products to ensure quality, safety, and efficacy. The facilities will be operated and marketed to support the advancements of clinical applications of regenerative medicine for the benefits of patients in Hong Kong and the Greater Bay Area.
Xellera is also the industry partner and sponsor for a recent grant from the Innovation and Technology Commission (ITC) of the Hong Kong SAR Government awarded to the collaborating group consisting of the Hong Kong Red Cross Blood Transfusion Service and the Department of Paediatrics and Adolescent Medicine of Queen Mary Hospital, the University of Hong Kong (HKU) and the Scottish National Blood Transfusion Service and University of Edinburgh for establishing the first clinical-grade human induced pluripotent stem cell (iPSC) haplobank for Southern Chinese in Hong Kong and other cities within the Greater Bay Area. These clinical-grade iPSCs have the unique ability of becoming all cell types of the body, including non-regenerative heart, brain, eye lineages, etc, for human transplantation without immunorejection. The project is expected to greatly enhance the development of next-generation therapeutics in the region by providing immunologically-matched cell sources for a range of conditions from heart diseases, spinal injuries to blindness. This co-sponsored grant with ITC, totalling to over HK$30M, indicating the commitment to developing next-generation therapeutics.
In addition to the above, Xellera is also manufacturing clinical-grade mesenchymal stem cells and other ATMPs and launching several clinical trials with details to be announced separately.
“We are very excited about the establishment of the very first commercial cGMP facilities for ATMP in the city. What once could only be imported can now be made available locally or regionally to benefit patients in Hong Kong and other cities within the Greater Bay Area,” said Xellera Founder and Board Member Prof. Ronald Li, “Building a clinical-grade human iPSC haplobank with the facilities is a first step to benefit a broader patient base with next-generation therapeutics.”
Prof. Marc Turner, our Chair of the Scientific Advisory Board for GMP, giving his opening remarks at Press Conference