Chinese CDMO GenScript Biotech already has a deal to produce a CAR-T drug being developed by its Legend Biotech unit and Janssen. But the contract manufacturer has started construction on a production facility to specialize in plasmids and viruses manufacturing for other clients as well.
GenScript Monday kicked off the project with a groundbreaking at a site in Zhenjiang, China. It says the 150,000-square-meter facility is being designed to meet FDA and EMA standards as well as China’s National Medical Products Administration.
The company 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 III clinical supplies and commercial production. Details on what the CDMO is investing or when the facility is slated to be complete were not provided.
Legend Biotech’s vice president of production Dr. David He said in a statement that Legend has a commercial production facility in the U.S. that is about ready to open but that in China it will work with GenScript. The CDMO also has a contract for two CAR-T projects under development by China’s Shanghai Longyao Biotechnology.
Johnson & Johnson’s Janssen in 2017 agreed to pay Legend $350 million upfront for U.S. and European rights to its CAR-T candidate after the biotech reported data at ASCO demonstrating its candidate could be a safe and effective way to treat relapsed or refractory multiple myeloma. JNJ-682845 has already been submitted for approval in China.