Biologics manufacturing centre
GenScript Biotech is constructing a biologics manufacturing centre in Zhenjiang city, Jiangsu Province, China.
The new facility is anticipated to be the first and largest commercial centre for research and development of cell and gene therapies and antibody biologics in the country.
The $75m facility will be used for the discovery, development and clinical and commercial manufacturing of biologics at one place. It will enable the company to improve the biologics discovery and development services provided to its partners worldwide.
Ground-breaking on the construction of the project took place in April 2019. The facility is expected to be operational by 2020. It will employ more than 400 people.
GenScript signed an agreement with Zhenjiang New Area Administrative Committee to lease a 7,899.6m² factory in Zhenjiang New Area for the development of the biologics manufacturing centre along with warehouse facilities. The lease agreement also includes rights to increase the total reserved land area.
Zhenjiang New Area covers a total area of 82km² and includes various chemical, electronic and hi-tech industry development, as well as multi-national companies from more than 20 countries.
The state-of-the-art biologics manufacturing centre will span across 133,000m² and have a gross floor area of 150,000m². It will specialise in manufacturing of commercial products such as plasmids and viruses for development of cell and gene therapies.
The facility will be equipped with 200l, 500l, and 2,000l cell culture bioreactors. The total production capacity of the facility will be approximately 5,700l.
The plasmid production line will feature single-use bioreactors, while the virus production line will feature suspension and adherent-based production technologies. The production lines will have a combined output capacity to cater to different commercial projects simultaneously.
Different spaces for production, filling and quality control will be featured in the manufacturing centre. It will be equipped with cold chain logistics for biologics and warehouse for raw and supplementary materials.
Design and construction of the centre will be carried out in compliance with the current good manufacturing practices (cGMP), according to the guidelines of the US Food and Drug Administration (FDA), the National Medical Products Administration (NMPA) and the NMEA.
The facility will be used to produce JNJ-4598 (JCAR-B38M), an investigational chimeric antigen receptor T-cell (CAR-T) therapy, which is being developed by GenScript’s subsidiary, Legend Biotech.
The therapy is meant for the treatment of multiple myeloma and has received FDA clearance for clinical development.
Other projects, including those involving plasmid and virus production such as CAR-T, UCAR-T, T-cell receptor (TCR) and adeno-associated virus (AAV) gene therapy, will also be developed at the facility.
The manufacturing facility will produce clinical samples for late-stage clinical development along with commercial production. It will support the company to provide turnkey services for commercialising gene and cell therapy products.
Founded in 2002, GenScript Biotech is a biopharmaceutical contract development and manufacturing organisation (CDMO) based in China.
The company provides services for antibody development, gene and peptide production and development of customised biological reagents. It also offers a one-stop platform for research and development of a biological drug, which includes antibody drug development, antibody engineering and other services.
GenScript Biotech plans to make a significant contribution to the development of the Chinese pharmaceutical industry under the Made in China 2025 plan.
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