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CUHK and HKSTP to establish a world-class GMP facility

Image Credits: HKSTP, Press Release

The Chinese University of Hong Kong (CUHK) and Hong Kong Science and Technology Parks Corporation (HKSTP), recently announced their partnership to build a world-class Good Manufacturing Practice (GMP) facility in Hong Kong to accelerate the development of life-saving cancer therapies, regenerative medicine, and related biomedical technologies.

As the city’s biomedical sector undergoes accelerated growth, there is an increasing demand for supporting facilities that comply with PIC/S GMP standards, required for the development and manufacture of Advanced Therapy Products (ATPs). These products, including those for stem cell therapy, gene therapy and immunotherapy, can potentially provide new and life-saving treatments for diseases with limited or no treatment options including cancers, cardiovascular and neurological diseases.

To facilitate the development of this emerging class of medicines, and safeguard public health, the HKSAR passed the Pharmacy and Poisons (Amendment) 2020 Ordinance (CAP. 138), which provides that the requirements for pharmaceutical products under this ordinance shall also apply to ATPs. All manufacturers of ATPs will need to obtain a licence to fully comply with the PIC/S GMP standards when producing such products for both clinical trials and the commercial markets.

In response, CUHK and HKSTP are joining forces to establish a GMP facility for cell therapy, as part of their strategic collaboration to accelerate translational medicine development.

The CEO of HKSTP stated that the partnership with CUHK addresses a great public health challenge. Building this world-class GMP facility will bridge the gap between Hong Kong’s thriving biomedical technology development with the international healthcare sector. It also brings top researchers from academia and promising start-ups together, to advance Hong Kong’s international position in biomedical technology.

The Pro-Vice-Chancellor and Vice-President of CUHK remarked that the university has always been committed to promoting research development in Hong Kong. The University is very pleased to be collaborating with HKSTP in establishing a world-standard GMP facility.

The partnership is good news for both CUHK and the industry as this facility provides an ideal environment for researchers with expertise in cell therapy and regenerative medicine in Hong Kong to implement clinical trials, as well as receiving support in research and professional training. The university head strongly believes that it will bring breakthroughs in cell therapy in the future and will benefit more cancer patients.

The facility aims to accelerate the development of ATPs from bench-to-bedside while stimulating the testing and commercialisation process. Clinical trials in cell-based cancer therapies such as chimeric antigen receptor T-cell (CAR-T) and stem cell-based regenerative therapies will be the initial focus of the facility. As part of the launch, relevant scientists and operators will receive training to operate, audit and regulate both the facility and the products manufactured.

The sophisticated GMP facility will be built inside the Hong Kong Institute of Biotechnology (HKIB), a CUHK subsidiary which is strategically situated in between CUHK campus and Hong Kong Science Park. The facility will span more than 3,800 square feet and is scheduled to be in operation in early 2021 and is expected to be fully compliant with the highly stringent international PIC/S standards shortly after opening.

According to a report from 2017, at the time, it was estimated that Hong Kong had approximately 250-300 biotechnology-related companies, comprising of mainly healthcare-related companies with business on pharmaceuticals, medicinal or healthcare products of traditional Chinese medicine origin, and medical devices and diagnostics.

Activities engaged by these companies generally include product research & development, manufacturing, marketing and sales. Because of Hong Kong’s strategic geographical location and the huge economic potential of the Chinese market, there is a constant stream of overseas biotechnology companies interested in setting up regional headquarters or offices in Hong Kong to capitalize on the growth of the region.

With the ongoing pandemic, biotechnology firms and innovations will likely continue to grow, placing Hong Kong in the right circumstances to become a global biotech hub.

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