As part of a deal by Hitachi Chemical to acquire a 19.9% equity interest in Caladrius Biosciences' ($CLBS) PCT cell therapy and manufacturing subsidiary, the Japanese conglomerate will assist in developing new automated manufacturing facilities for the production of regenerative medicine cells.
|Hitachi Chemical CEO Kazuyuki Tanaka|
The $19.4 million price tag for the deal, announced recently, gives Hitachi the license to PCT's cell therapy technology and expertise for cell therapy manufacturing in certain Asian territories, including Japan, the companies said in a release. Japan's Pharmaceuticals and Medical Devices Agency has introduced legislation the two companies see as more favorable for stimulating the growth of regenerative medicine in that country.
"By leveraging PCT's expertise and cell therapy technology, complementing PCT's capabilities with our own and launching joint initiatives in new geographies, we will advance together towards that goal (of establishing a global leadership in regenerative medicine)," Kazuyuki Tanaka, president and CEO of Hitachi Chemical, said in a statement.
Tanaka added that Hitachi Chemical will get "technological assistance" from its parent corporation "to develop a production control system, including automated facilities, to manufacture low cost yet high quality regenerative medicine cells, while also promoting consumable materials such as containers and reagents."
PCT has a 30,000-square-foot facility in Allendale, NJ, that is being expanded to produce European Union-compliant cell therapy products, and a 25,000-square-foot cell therapy plant in Mountain View, CA. Both facilities are GMP compliant.
"Hitachi Chemical's investment in PCT shows its confidence in the growth of the cell therapy field as the field continues to shift towards Phase 2 and Phase 3 trials and into commercial distribution as regulatory approvals are obtained," Robert A. Preti, president of PCT, said in a statement.
Last week, PCT was hired by French biotech TxCell to handle the company's clinical supply manufacturing in the U.S. TxCell's plant in France was shut down last year by regulators because of mold issues.
- check out the release