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February 7, 2022, National Cancer Center Japan (“NCC”), a national institution to be a hub for cancer treatment and research founded in 1962 in Japan, GenScript Biotech Corporation (Stock Code: 1548.HK), a world's leading technology and service provider of life science R&D and manufacture, and ProBio, a leading CDMO in biologics and gene cell therapy segment of GenScript Biotech, today announced the companies have entered into an agreement to start a project of plasmid & lentiviral vector CMC development.
The project initialized by National Cancer Center Research Institute. Under the agreement, National Cancer Center and GenScript Biotech will collaborate on a CMC research to develop plasmid and lentiviral vector for cell therapy to aim on FDA acceptance of Investigational New Drug (IND) applications. The project will be proceeded and accomplished in facilities of ProBio, meets the requirement in the manufacture of critical starting material of IND used in clinical trials. During the research term, both parties will leverage their respective expertise, including ProBio's GMP manufacturing facilities and National Cancer Center’s profound knowledge of cancer research.
ProBio has established the largest commercial cGMP plasmid manufacturing facility in China, it also is the first CDMO enterprise in China to have a separate production facility for plasmid and viral vector and the first cGMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines. Leveraging its global resources and presentations, ProBio not only has supported several mRNA vaccine enterprises to obtain clinical approvals by China’s NMPA, it also helped mRNA vaccine projects of South Korea and the United States customers to obtain clinical approvals by KFDA in South Korea and PMDA in Japan successfully.
In addition to maintaining a leading position in the field of plasmids, ProBio has also continuously strengthened its capabilities in the field of viral vector. ProBio has a stable and high-yield viral vector platform, which has made it the first lentiviral vector CDMO and the leading AAV supplier in China. It owns self-developed lentiviral vector suspension cell line “PowerSTM-293T”, which shows greater advantages in the yield and stability of the lentiviral vector than the most widely used cell line in the market at present.
“We're delighted to collaborate with National Cancer Center Japan to accelerate its plasmid & lentiviral vector CMC development program,” said Dr. Brian Min, CEO of ProBio. “We believe our high-quality plasmid & viral vector manufacturing platform and accumulated experiences in the cell and gene therapy fields, together with joint efforts of our partners, will bring the promising cell therapy to market sooner and benefit more patients.”
“GenScript Japan has established and served Japanese customers with our proprietary gene synthesis technology and other life-science research and applications in the past 10 years, with bringing our newest biologics CDMO platform and other cutting-edge technologies to Japan market, GenScript group is dedicated to enabling more and more Japanese researchers and scientists like National Cancer Center Japan to bring their innovative treatments to patients, as well as speeding up the evolution of Japan pharmaceutical industry through our integrated services. “ Said Dr. Alex Liu, Head of GenScript Japan.
The National Cancer Center was founded in 1962 as a national institution to be a hub for cancer treatment and research. Since its establishment, as an institution that serves as a nucleus of clinical research and development for cancer treatment, the Center has led cutting-edge research aimed at elucidating the pathophysiology of cancer and developing treatments based on it, with integrating its insight and experience accumulated by experts at the National Cancer Center Research Institute, the National Cancer Center Hospital (Tsukiji campus) and the National Cancer Center Hospital East (Kashiwa campus). In addition, the number of clinical trials conducted is one of the highest in Japan, and also both the Hospital and the East Hospital have been accredited as a “clinical research core hospital” under the Medical Care Act, since then leading world class clinical research such as Phase I trials and investigator-initiated trials, contributing to the establishment of new standard treatments.
In particular, at present, the Center is vigorously reinforcing its research and clinical systems to address unmet medical needs, developing a framework based on genomic information to provide personalized treatment as well as systemized preemptive medical care for individual patients, and policy advocacy. The Center is actively collaborating with companies, industrial and academic research institutions and universities.
For more information on the National Cancer Center, please visit https://www.ncc.go.jp