ALLENDALE, N.J.--(BUSINESS WIRE)--Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) announced today that they have signed a three-year clinical manufacturing agreement with GSK, a science-led global healthcare company. Under the agreement, HCATS will manufacture GSK’s SPEAR T-cell receptor therapy targeting NY-ESO-1 for the US, Canadian and European trials. NY-ESO is expressed across a variety of tumors including sarcomas, melanoma, multiple myeloma, bladder cancer, non-small cell lung cancer, ovarian cancer and gastro-intestinal cancers.
HCATS is a US subsidiary of Hitachi Chemical Co. Ltd. that engages in contract manufacturing and development of cell-based cell and gene therapy products through its PCT Global Service Platform.
“Since becoming part of Hitachi Chemical over a year ago, we have seen increasing interest in leveraging our PCT Global Service Platform both in the United States and Japan,” said Robert A. Preti, PhD, CEO and President of HCATS and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector. “This agreement is an exciting step for our growing global enterprise, advancing our vision to support efforts to make these transformative therapies accessible to all.”
“We are extremely proud and grateful to enter into a relationship with GSK, as it provides the opportunity to partner with an industry leader,” said Sanjin Zvonić, PhD, Senior Director, Business Leader, Clinical and Commercial Manufacturing of HCATS. “As with all our clients, we are committed to delivering high-quality, compliant, flexible, scalable, and cost-effective manufacturing services.”
About Hitachi Chemical Advanced Therapeutics Solutions
Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS, formerly PCT Cell Therapy Services, LLC), is a wholly owned subsidiary of Hitachi Chemical Company, Ltd. (Hitachi Chemical) representing Hitachi Chemical’s Regenerative Medicine Business Sector in the United States. HCATS leverages nearly two decades of experience exclusively focused on the cell therapy industry. It provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. Facilities to deliver these services under a global harmonized service platform have been established in Japan (Yokohama City, Kanagawa Prefecture), and in the United States (New Jersey and California), with an expansion to add commercial manufacturing capabilities and capacity underway in New Jersey. For more information about these services, please visit www.pctcelltherapy.com