China's Largest Plasmid and Virus Facility from GenScript in Operation
The CDMO segment of the world's leading biotech company GenScript announced that GenScript's plasmid and virus facility was put into operation on December 18, 2019. It is a milestone on the path to the industrialization of the gene and cell therapy industry, pioneered by GenScript. GenScript's plasmid and virus facility are going to be China's largest plasmid and virus facility that meets the needs in the clinical stage.
The virus facility that put into use in Zhenjiang has been built in strict compliance with GMP and is completely used for the manufacturing of viral vectors in gene and cell therapy products. The facility has the capability to manufacture viral vectors for clinical phase I/II. As the facility was designed and constructed by the team from an international professional pharmaceutical company, the facility features first-class design and capacity in the industry.
At this event, Dr. Brian Min, CEO of GenScript BDBU delivered a speech. Dr Brian said, "Cancer treatments have been evolving nowadays. With the rapid development of life sciences and medicine, gene and cell therapy (GCT) technology has been one of the areas most concerned in recent years. GenScript has made remarkable achievements in GCT. In response to expedited industrialization of the GCT market, with 17 years of CRO experience, GenScript has engaged BDBU in biologics CDMO and developed and innovated in our GCT vector platform, helping GCT customers address vector production challenges during product development. Supported by powerful manufacturing teams, advanced technology, and rich experience, GenScript has consistently offered customized services to customers and practised the individualized management model. GenScript is able to help customers effectively diversify risks, lower costs and shorten the production cycle, promoting the industrialization of GCT products. With experience in more than 10 IND programs and more than 50 batches of pilot-scale production, GenScript will continue to provide customers with optimum services. GenScript is expected to contribute to the development of the GCT industry."
The guests visited GenScript plasmid and virus facility. The total facility area is about 5,000m2, and is currently the largest plasmid and virus facility in China. Both plasmid facility and virus facility are equipped with 4 parallel production lines, which allows more than 20 process development projects to be conducted in the whole year. The team leaders from GenScript Gene and Cell Therapy Vector Platform have more than 10 years of experience in vector manufacturing, and the platform is currently working on over 10 IND projects. The overall design, layout and quality management system of the facility is established in strict compliance with GMP. The GMP virus facility put into production this time can provide customers with clinical viral vectors manufacturing services and help to accelerate the conversion of the projects from preclinical research to the clinic.
GenScript will also provide commercial manufacturing of plasmid and virus in the near future. The ground-breaking of the commercial manufacturing was held in April 2019 and will be officially put into production in the first quarter of 2021. By then, GenScript will become the first CDMO in China to have a commercial manufacturing centre for gene and cell therapy vectors, providing customers with a one-stop solution from clinical to commercial services, thereby accelerating the IND application of gene cell therapy products and promoting development of industrialization of gene and cell therapy.