Mar, 2024
CUHK’s HKIB takes another leap forward:
Advanced Therapy Product GMP Centre is the first university-led centre to receive manufacturing licence and certificate

Source: CUHK News Centre 2024-03-12

The Advanced Therapy Product Good Manufacturing Practice Centre (ATP GMP Centre) at the The Chinese University of Hong Kong’s (CUHK) Hong Kong Institute of Biotechnology (HKIB) is proud to announce that it has been granted both a Certificate for Manufacturer and a Licence for Manufacturer for clinical trials by the Pharmacy and Poisons Board of Hong Kong. It makes the HKIB ATP GMP Centre (the Centre) the first university-led facility in Hong Kong to receive these certifications for ATP manufacturing.

Starting with manufacturing Chimeric Antigen Receptor T cells (CAR-T) for blood cancer clinical trials, this breakthrough accreditation opens up a world of possibilities for realising the potential of promising cell gene therapies, allowing them to be delivered to patients more quickly and affordably. Currently in Hong Kong, CAR-T is manufactured overseas, making them time-consuming and expensive. With local manufacture as a coming option, the turnaround time of CAR T-cell therapy could be shortened from several months to just two weeks, and the cost could be reduced substantially by a third.

HKIB’s ATP GMP manufacturing licence and certificate is recognised internationally and a passport to initiate multinational clinical trials, as the Pharmacy and Poisons Board of Hong Kong is a member of the international Pharmaceutical Inspection Co-Operation Scheme (PIC/S). For homegrown ATPs made at HKIB to go abroad is the prerequisite to accelerate translational medicine research in Hong Kong and the wider Greater Bay Area (GBA) to reach a global scale. It will also be an attractive incentive to bring international biotech and pharmaceutical companies to come to the region and conduct cutting-edge, life-saving clinical trials.

Director of HKIB Dr Gina Jiang said, “Receiving the landmark GMP manufacture certificate for ATP is pivotal for translational research to enter the clinical trial phase. It is also a testament to our commitment to advancing biomedicine and our strive for safety, quality and compliance with a patient’s best interest in mind. In addition to the immediate social and economic impacts, manufacturing ATPs that can access and be part of the thriving cell gene therapy global arena aligns perfectly with the Hong Kong government’s policies to create a clinical trial network in the GBA and a must-have to make Hong Kong a key player in the global biotech industry.”

To further support biotechnology advancement in Hong Kong, the HKIB and the Chinachem Group have signed a Memorandum of Understanding (MOU) to explore a potential Process Development facility for pre-GMP activities. This partnership aims to speed up Cell Gene Therapy development and foster cross-industry and interdisciplinary collaboration in translational biomedicine.

The Hong Kong Institute of Biotechnology (HKIB) was established in 1988, funded by the generous donation of The Royal Hong Kong Jockey Club (renamed The Hong Kong Jockey Club in 1997). In 2000, HKIB becomes an affiliate of The Chinese University of Hong Kong. The HKIB ATP GMP Centre, in collaboration with The Chinese University of Hong Kong, The Hong Kong Science and Technology Parks Corporation (HKSTP) and HKIB, brings together top-notch Hong Kong talent in pharmaceutical industry and academia in Cell Gene Therapy, provides a state-of-the-art GMP facility for the production of ATPs. By offering a full value chain from bench to bedside, the Centre greatly strengthens Hong Kong’s competitive advantages and positions the city as a major global hub for strategic development in biotech and health sciences enterprises.

More information on the HKIB ATP GMP Centre:

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Hong Kong Institute of Biotechnology Advanced Therapy Product Good Manufacturing Practice Centre is the first university-led centre to receive a manufacturer’s certificate and licence.


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