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GenScript ProBio to Expand Commercial cGMP Plasmid and Viral Vector Manufacturing Facility in Zhenjiang, China

The new facility will be utilising the latest technology and equipment in viral vector and plasmid manufacturing to scale up its production capacity and deliver end-to-end cell and gene therapy capabilities.

GenScript ProBio, a global antibody and gene therapy contract development and manufacturing organisation (CDMO), has announced 2022 manufacturing expansion plans to meet the increasing demand for commercial cGMP plasmid and viral vector manufacturing to service its cell and gene therapy global clients. On January 19, 2022, GenScript ProBio broke ground for the construction of its newest plasmid and viral vector manufacturing facility, a 34,000-square-meter cGMP facility in Zhenjiang, Jiangsu. This is an important measure taken by GenScript ProBio to quickly respond to the global biopharmaceutical market demand and further expand the commercial capacity of plasmid and viral vectors after the company’s largest commercial plasmid GMP manufacturing facility in China was put into operation.

GenScript ProBio’s new facility will be state-of-the-art, utilising the latest technology and equipment in viral vector and plasmid manufacturing to scale up its production capacity and deliver end-to-end cell and gene therapy capabilities. The expansion project includes a plasmid centre and viral vector centre, which will house plasmid and virus manufacturing facilities and manufacturing science and technology (MSAT) laboratories. The entire facility will be designed in compliance with the cGMP requirements of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and National Medical Products Administration (NMPA).

The plasmid cGMP manufacturing facility comprises four production lines. The initial upstream line will include two 10L–50L sized bioreactors and one 50L-300L bioreactor. The fourth line will be planned with the second phase of expansion, with an expected capacity of 1,000L-2,000L. The viral vector cGMP manufacturing facility comprises six upstream production lines, three downstream production lines, and two filling lines with a range of capacity from 50L to 2,000L. With the implementation of a single-use/disposable bioprocess platform, it will increase the total viral vector production scale to 5,000L up to 200 batches annually. These expansions will further enhance GenScript ProBio’s commercial capability to offer high-quality, end-to-end service from discovery to clinical production with faster delivery.

Previously on December 7, 2021, GenScript ProBio announced plans to build the largest commercial cGMP plasmid manufacturing facility in China in Zhenjiang, Jiangsu Province, effectively consolidating its leading position in the CDMO field and increasing its productivity with more than doubled plasmid production capacity. The launch of the commercial cGMP plasmid manufacturing facility makes GenScript ProBio not only own the largest commercial cGMP plasmid manufacturing facility in China, but also the first CDMO enterprise in China to have a separate production facility for plasmid and viral vector and the first cGMP manufacturing platform in China to provide in vitro transcription (IVT) template linearised plasmids for mRNA vaccines. Many projects for a COVID-19 mRNA vaccine from China have been carried out in GenScript ProBio›s plasmid manufacturing facility. 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.

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 vectors. GenScript ProBio has a stable and high-yield virus vector platform, which has made it 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 a 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. “PowerSTM-293T”, a self-developed suspension cell line, produced AAV by co-transfection of three plasmids, and has higher titre and lower impurity level in a variety of serotypes. These two self-developed cell lines by GenScript ProBio have significantly reduced the cost of lentiviral vector and AAV production without compromising quality.

“The CDMO business of GenScript ProBio has been the key business of GenScript Biotech Corporation in recent years,” said Sherry Shao, COO of GenScript Biotech Corporation. “And GenScript Biotech Corporation also pays close attention to and expects the future development of GenScript ProBio. GenScript ProBio is constantly expanding in the field of cell and gene therapy, and we look forward to using our cutting-edge technology and innovative business model to accelerate the development of the global cell and gene therapy industry and support more clients to achieve success.”

“The cGMP plasmid manufacturing facility laid out this time is another important measure for the construction of GenScript ProBio’s platform,” said Mr Daniel Wang, Senior Vice President of GenScript ProBio. “Our proprietary platform, the capability of generating stable, high-yield viral vector platform, and position as the largest cGMP-certified plasmid manufacturing provider in China, are clear advantages we can offer customers in the cell and gene therapy market. We look forward to enabling access to life-changing gene therapies and empowering cell and gene therapeutic companies to make advanced therapies more efficient and accessible to patients.” [APBN]

Source: GenScript ProBio