07 February 2022 | Monday | News
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 GenScript 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 GenScript ProBio's GMP manufacturing facilities and National Cancer Center’s profound knowledge of cancer research.
GenScript 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, GenScript 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, GenScript ProBio has also continuously strengthened its capabilities in the field of viral vector. GenScript 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 GenScript ProBio. “We believe our high-quality plasmid & viral vector manufacturing platform and accumulated experiences in the gene and cell 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.