With Western drugmakers taking new-generation meds to China, GenScript Biotech is looking to be a key player in China’s CDMO market for biologics and cell and gene-based treatments. The Chinese company this week formally premiered a clinical supply manufacturing facility even as it is working on a commercial-scale facility nearby.
GenScript has opened a 9,300-square-meter (100,104-square-foot) clinical supply biologics production and R&D facility in Nanjing that was completed in June. The company said it meets both FDA and EMA standards.
“At the beginning of 2019, we established a foothold in the biologics sector as an independent business,” Brian Min, CEO of biologics for GenScript Biotech, said in a statement. “GenScript's planned biologics commercial production center will be the first and largest such facility in China covering cell therapy, gene therapy and antibody drug R&D. We will be able to meet the rapidly evolving demands of gene and cell and antibody and protein therapies.”
GenScript in April began construction on that facility which will be capable of doing plasmid and virus manufacturing. The 150,000-square-meter facility in Zhenjiang is also being designed to meet FDA and EMA standards as well as those of China's National Medical Products Administration.
The company has said the plasmid service line will be equipped with single-use bioreactors while the virus line will use suspension-based production processes. It said the facility will be able to handle phase 3 clinical supplies and commercial production. It expects to have the facility in production in 2020.
The GenScript facility already has a deal to produce a CAR-T drug being developed by its Legend Biotech unit and Janssen.