Cellular Biomedicine, a biotech working in the hot new area of treating cancer by creating CAR-T cells, has opened another facility in China.
California-headquartered Cellular Biomedicine is developing stem cell products for joint and autoimmune disorders, and has in-licensed CAR-T immuno-oncology technology from the Chinese PLA General Hospital of Beijing.
Cellular Biomedicine, which has operations in both Shanghai, China, and Cupertino, CA, said this week that it has opened a 1,400-square-meter (15,069-square-foot) facility in the PKUCare Industrial Park in Beijing. It said that 800 square meters of the facility has been equipped with four production lines that can produce product for both clinical work and commercial production.
The company said that with the opening of this facility, it now has three GMP facilities in China with 9 independent production lines. Together they give the company enough capacity to process more than 200,000 individual cell sources. The facility has received certification from the Beijing Institute for Drug Control, accredited bodies of the China National Accreditation Service and China Metrology Accreditation.
Cellular's announcement comes as a number of companies are preparing to submit applications for their CAR-T treatments to the FDA and have or are working on facilities that can handle the individual processing that the treatments require. Furthest along is Swiss drugmaker Novartis ($NVS), which paid then-struggling Dendreon $43 million in 2012 for a 173,000-square-foot plant in Morris Plains, NJ, that Dendreon had been using to make its own personalized therapy, cancer vaccine Provenge.
Kite Pharma ($KITE) and Juno Therapeutics ($JUNO), which have been relying on contract manufacturers, are working on facilities in the U.S. that will allow them to handle clinical supplies and eventually commercial production. Kite also picked up some capacity in Europe with a recent deal for a Dutch company.
The big question that the drugmakers have is how to make the processing of individualized treatments like these cost-effective, one of the challenges that led Dendreon to file for bankruptcy and put itself up for sale last year. Novartis has indicated its process will take about two weeks to complete. Usman Azam, who heads Novartis' cell and gene therapies area, told Reuters recently that the company was confident it would be able to scale up production to thousands of patients a year with the facility it got from Dendreon and be able to handle demand for several years. He said at that point, the drugmaker can decide if a second plant is needed.
- here's the announcement