In the first of its kind in Hong Kong, The Chinese University of Hong Kong (CUHK) and Hong Kong Science and Technology Parks Corporation (HKSTP) today formally opened the Advanced Therapy Products (ATP) Good Manufacturing Practice (GMP) Centre located at the Hong Kong Institute of Biotechnology Limited (HKIB), adjoining the Science Park.
The brand-new centre provides a Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP-compliant facility that will produce clinical grade ATPs for approved clinical trials and treatment. GMP is a global system for ensuring that products are consistently produced and controlled according to quality standards. The centre will foster collaboration between government, academic institutions, and the industrial and commercial sectors with the goal of establishing a world-class cell and gene therapy (CGT) manufacturing industry in Hong Kong and the Greater Bay Area.
The global CGT market is exploding. Technological development and unmet clinical needs have been accelerating the number of CGT products entering into clinical trials. China is feeling this urgency today, as it ranks second globally for total clinical trials. Worldwide, there are more than 60,000 patients currently participating in CGT clinical trials, yet the average waiting time is 18 months just to access a GMP clean room to produce CGT products.
The new ATP GMP Centre features six operationally segregated clean rooms, all PIC/S GMP-compliant and designed specifically for CGT product manufacturing and multiple ATP processes. This will accelerate the development of CGT treatments from the clinical trial stage to full commercial-scale production and dramatically improve time to market.
Professor Rocky S. Tuan, Vice-Chancellor and President of CUHK, said, “The CUHK ATP GMP Centre represents a significant development in the innovation and research agenda of Hong Kong, and is also a realisation of the ambitions and aspirations of our former Vice-Chancellor, the late Professor Sir Charles Kao, who envisioned biotechnology as critical to the future prosperity of Hong Kong and established the Hong Kong Institute of Biotechnology at CUHK in 1988. The new Centre combines the proven capabilities of CUHK and the HKSTP to accelerate the development of life-saving cancer therapies, regenerative medicine, and related biomedical technologies, and enable the translation of scientific research into tangible benefits for patients in Hong Kong and beyond. It also creates a fertile breeding ground for talented researchers and practitioners who contribute to the sustainable future of Hong Kong.”
Mr Aldous Mak, CFO of HKSTP, said, “The opening of the CUHK ATP GMP Centre is a landmark moment in the vision to establish a world-class cell and gene therapy manufacturing industry in Hong Kong and the GBA. HKSTP is thrilled to be working with CUHK, our long-term partner, in bringing this critical addition to Hong Kong’s fast-growing biotech infrastructure landscape to further accelerate the translation of scientific discoveries into life-saving biomedical innovations to benefit societies around the world. The collaboration not only accelerates R&D work in ATP, but also makes vital treatment and care more available for more patients.”
The ATP GMP centre offers academic and non-academic collaborators flexible manufacturing solutions without the capital investment of building their own facilities. The centre features a highly skilled workforce, cluster development and excellent logistics infrastructure. Collaborators can access several segregated modules to manufacture their own products. The centre will also provide a unique ATP GMP key personnel training ground, promoting translation of academic research in response to changing and new industry demands.