HKSTP and HKU Collaborate to Establish State-of-the-Art PIC/S GMP Facility for Advanced Cell Therapies

(Hong Kong, 23 May 2023) – The Hong Kong Science and Technology Parks Corporation (HKSTP) and the LKS Faculty of Medicine, the University of Hong Kong (HKUMed) today announced the launch of HKU-HKSTP Collaborative Programme and the opening of HKUMed Laboratory of Cellular Therapeutics, a leading-edge GMP laboratory to safeguard public health and facilitate the development of advanced therapy products (ATPs). This milestone enables new lines of research and production of ATPs, including stem cell therapy for cardiac diseases and CAR-T cell therapy for blood cancers led by Professor Tse Hung-fat and Professor Eric Tse Wai-choi, respectively. The products manufactured would benefit new patient groups with a broad indication, and to boost development of innovative therapy with more clinical experience acquired.

The HKUMed GMP Lab aims to manufacture clinical-grade ATPs as investigational medicinal products (IMP) for clinical trials and to provide a brand-new unique training platform for scientists and clinicians. This is Hong Kong’s first GMP multi-products facility with approval in principle from the HKSAR Department of Health for an ATP manufacturing license. The facility will also serve as a Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP-compliant training centre for key personnel involved in ATPs manufacturing, quality control and assurance.

Talent training and international collaboration are keys to establish a hub for ATPs development in Hong Kong. The HKUMed GMP Lab’s joint training programme with the Scottish National Blood Transfusion Service (SNBTs) and University College London (UCL) has produced a group of competent staff to operate the facility. HKU is also developing ATP translational training at undergraduate and postgraduate levels in collaboration with international partners from UCL and Cell Therapies Pty Ltd in Melbourne. The launch of the HKUMed GMP Lab offers unparalleled learning opportunities in developing gene and cell therapies, as well as serving as a stepping stone in transforming HKUMed’s research discoveries into real products.

In terms of commercialisation of local research breakthroughs, the HKUMed GMP Lab will collaborate with biotechnology companies on GMP projects and pilot trials. Clinical trials on CAR-T and stem cell therapies are targeted to be available in five years, which aim at benefiting non-cancer patients as well. To pave way for commencing product development in the upcoming Jockey Club Centre for Clinical Innovation and Discovery at Grantham Hospital, equipped with GMP laboratory for gene and cell therapy in tenfold scale, the HKUMed GMP Lab will collaborate with pharmaceutical companies in the localised manufacturing of cellular products for such as CAR-T therapies.

Dr Grace Lau, Head of Institute for Translational Research, HKSTP said, “The GMP facility will be pivotal in readying promising research by local universities and biotech companies for translation into clinical applications. HKSTP is committed to cementing Hong Kong's position as Asia's leader in biomedical technology. This includes providing critical infrastructure and gaining international recognition to attract investment and forge strategic partnerships. The HKU-HKSTP Collaborative Programme will further strengthen Hong Kong's ATPs ecosystem and substantially enhance the city's competitiveness in the global market for research and commercialising next-generation cell and gene therapies.”

“We believe HKU is consolidating top industry talents to establish its leading role as an ATP training hub in Hong Kong and the Greater Bay Area,” said Professor Tse Hung-fat, academic lead of the HKUMed Laboratory of Cellular Therapeutics.

Professor Tse remarked, “I wish to express our sincere gratitude to our funding bodies, the Hong Kong Science and Technology Parks Corporation, The Queen Mary Hospital Charitable Trust, the Innovation and Technology Commission, Ng Teng Fong Charitable Foundation, and Ms Amy Yeung Bick-yee. Last but not least, our training providers, Professor Marc Turner from SNBTs, Professor Ian Wong of HKUMed and Dr Dominic Wall from Cell Therapies Pty Ltd.”