On December 7th, the “Opening Ceremony of GenScript ProBio Plasmid Commercial GMP Manufacturing facility and Open Day” was rounded off. GenScript ProBio at the opening ceremony announced that the largest commercial GMP plasmid manufacturing facility in China is put into operation 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.
In 2020, it supported Suzhou Abogen to receive the first clinical approval for mRNA vaccine in China, and in October 2021, it further reached cooperation with Abogen and Walvax in commercial manufacturing of this vaccine. Besides supporting many mRNA vaccine enterprises in China to obtain clinical approvals by NMPA, GenScript ProBio also helped mRNA vaccine projects from South Korea and the United States companies to obtain clinical approvals in South Korea and Japan.
Dr. Brian Min, CEO of GenScript ProBio, delivered a speech at the opening ceremony, saying “GenScript ProBio adheres to the mission of‘Innovation through Collaboration’and it has provided high-quality plasmid viral vector manufacturing services for many customers around the world, and supported many customers to obtain clinical approvals depending on our rich experience in manufacturing and process development. Especially in the COVID-19 mRNA vaccine development, GenScript ProBio provides GMP plasmid manufacturing for mRNA vaccine clinical use for global customers with its strengths in GMP plasmid production platform and abundant clinical plasmid manufacturing experience. China is now in the rapid development of cell and gene therapy, and we are fully prepared to help our customers succeed and accelerate the development of global cell and gene therapy with our high-end technology and innovative business patterns.”
After the opening ceremony, the guests visited GenScript ProBio's GMP plasmid R&D and manufacturing facility. GenScript ProBio's scientists explained the layout of the facility, equipment’s production capacity and operation process in detail. The company already has rich experience in the design, construction and operation of 3 biopharmaceutical R&D centers and manufacturing facility. Therefore, the overall design, layout and quality system construction of the facility are based on sufficient industry experience, which also can reduce costs and improve the efficiency of biopharmaceutical research and development.
With the continuous and rapid development of the global biomedical industry in recent years, cell and gene therapy has become one of the hottest and most promising fields. Based on its formidable advantages in hardware and software such as self-developed core technology platform, professional and high-performing team, and the largest plasmids commercial GMP facility in China, GenScript ProBio is helping customers globally to achieve success as an important potential energy to accelerate the development of cell and gene therapy worldwide.