28th June 2023, Kathmandu
Biosyngen, an immuno-oncology company with technology targeting the unmet medical needs in solid tumor and lymphoma treatment, today announced the official opening of its latest Good Manufacturing Practice (GMP) facility in Singapore.
The facility will support cell manufacturing for immunotherapies in Singapore and across the world, and create more than 200 jobs for the cell and gene therapy (CGT) industry in the next three to five years.
The opening was officiated by Mr Alvin Tan, Minister of State for the Ministry of Trade and Industry, and executives from Biosyngen including Ms Joan Zhang, Chairman of Biosyngen, Prof Benjamin Seet, Board Member of Biosyngen, Dr Michelle Chen, Chief Operating Officer of Biosyngen and Prof Jean Paul Thiery, Chief Scientist of Biosyngen. The opening was also witnessed by distinguished guests from the Ministry of Health, Enterprise Singapore, Economic Development Board, SGX, A*STAR, and National Cancer Centre Singapore (NCCS).
The new facility is the first and largest privately-owned, fully automatic, enclosed, and integrated GMP cell manufacturing facility and Research & Development base in Singapore to date. The facility is compliant with the latest FDA (U.S. Food and Drug Administration) recommendation, enabling Biosyngen to run automatic and closed-system production – the preferred best practice in the CGT industry. Designed with containment within each production suite, this facility can support multiple clinical trials in parallel.
According to statistics from The Global Cancer Observatory (GCO), there were over five million deaths due to solid tumor cancers in Asia in 2020, accounting for 60% of the world’s mortality rate.[1] Most solid tumors respond poorly to conventional cancer treatments such as chemotherapy.[2] Biosyngen’s new GMP facility will leverage innovative capabilities to further the development of cutting-edge immunotherapies to improve treatment outcomes for such solid tumors.
“We started from humble beginnings in Singapore, renting a facility from Temasek Life Sciences Laboratory, and have now launched our new GMP facility. There is an urgency to increase speed in clinical trials for patients and build capacity for global needs, and Biosyngen is determined to take the lead in this space,” said Dr Michelle Chen, Chief Operating Officer, of Biosyngen.
Through years of extensive research, Biosyngen’s first-in-class products targeting nasopharyngeal cancer (NPC) and EBV+ lymphoma were granted Investigative New Drug (IND) approval by the US FDA and China National Medical Products Administration (NMPA). Its product targeting NPC was also recently granted the status of Orphan Drug Designation (ODD). In June 2023, the company submitted IND applications for two other indications, lung cancer, and liver cancer, to both the FDA and NMPA.
“Our facility in Singapore enables R&D in drug discovery and process development, and will also be able to accommodate more advanced processes or products that will be introduced in the future,” added Dr. Cecilia Zhang, Chief Scientific Officer, Biosyngen.
In Guangzhou China, Biosyngen also has the largest GMP cell production base in South China. Biosyngen has become the only immuno-oncology company in Asia with dual headquarters, dual fully automatic and enclosed GMP, and dual R&D layout. Biosyngen has achieved the simultaneous global development of innovative drugs and cost reduction of CGT drugs to the largest extent.
“We are a company dedicated to giving cancer patients a new lease of life by developing first-in-class immunotherapies. We aim to achieve this through our Research & Development (R&D) and collaborations with key stakeholders in hospitals, the wider industry, and governments.
Having two sites, one in Singapore and China, is a key global strategy for Biosyngen to advance the company’s product pipeline quicker, and drive R&D and GMP manufacturing from both sites,” said Isaac Chow, Chief Business Officer, Biosyngen.
Earlier this week, the company signed two key agreements to set up a China-Singapore Technology Innovation and Translational Medicine Centre for Tumour Prevention and Treatment as part of the Singapore-Guangdong Collaboration Council (SGCC), and a joint lab with Agency for Science, Technology, and Research (A*STAR) to develop multi-specific antibodies targeting solid tumors as part of the Singapore Economic and Trade Cooperation Council.
Biosyngen is also working closely with stakeholders in the Singapore healthcare ecosystem, collaborating with the National Cancer Centre Singapore (NCCS) to conduct a basket of clinical trials for various cancer indications and biomarker discovery to enhance patient selection and effectiveness.
In addition, the company has partnered with the Agency for Science, Technology, and Research (A*STAR) to develop multi-specific antibodies targeting solid tumors. The company also works closely with the Advanced Cell Therapy and Research Institute (ACTRIS) to consult on GMP practices and process development.
