GenScript ProBio announced the opening of its Commercial GMP Plasmid Manufacturing facility in Zhenjiang, Jiangsu Province. It enables the company to provide customers with one-stop service for plasmids including preclinical study (IIT), IND filing, clinical trial and commercial manufacturing, contributing to the development of high quality cell and gene therapy and accelerated innovation of mRNA drugs.
The commercial GMP plasmid manufacturing facility put into production this time is currently the largest one in China. It has a total floor space of 6,400m2. As the second GMP plasmid manufacturing facility of GenScript ProBio, it consolidates the leading position of GenScript ProBio in the CDMO field and further increases its productivity – providing more than doubled plasmid production capacity. After this commercial GMP plasmid manufacturing facility is put into operation, it enables the company to provide customers with services including off-the-shelf LentiHelpTM plasmids, Pro grade plasmids for preclinical stage, plasmids CMC study for IND filing, clinical GMP plasmids for early clinical trials and cGMP plasmid for late phase and commercialization, helping the cell and gene therapy to solve the problem of commercial GMP-grade large-scale plasmid production and manufacturing, and helping customers to commercialize their products in a more professional and efficient manner.
Previously, GenScript ProBio already own the largest plasmid vector manufacturing facility in China. When this commercial plasmid GMP production facility is put into operation, GenScript ProBio will not only own the largest commercial GMP plasmid manufacturing facility in China, but also the first CDMO enterprise in China to have separated production facility for plasmid and viral vector, and the only GMP manufacturing platform in China that provides in vitro transcription (IVT) template linearized plasmids for mRNA vaccines.
In addition to the plasmid technology platforms and expansion of manufacturing capacity, GenScript ProBio has a stable and high-yield viral vector platform, which has made the company the first lentiviral vector CDMO and the leading AAV supplier in China. GenScript ProBio has two core technology platforms: lentiviral vector and adeno-associated viral (AAV) vector. It owns self-developed lentiviral vector suspension cell line "PowerSTM-293T", and the viral vector yield of its lentiviral vector suspension production cell line is equivalent or even superior to that of the most widely used cell line on the market at present; the established AAV suspension production process platform has the self-developed AAV suspension production cell line PowerSTM-293 cells, which can reduce the cost while ensuring the product quality through triple transient transfection system.
Since its establishment, GenScript ProBio has been empowering the development of cell and gene therapy industry. In 2018, GenScript ProBio supported its subsidiary Legend Biotech to win the first CAR-T clinical approval in China. In 2019 and 2020, GenScript ProBio, as a service provider of of Xiangxue, helped them to complete the first TCR-T project approval of NMPA and the approval of FDA. The filing in China took only 54 working days from the submission of the IND application to the receipt of the Notification of Drug Clinical Trials, setting up a record for the fastest new drug approval in 2019 in China.
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