Hitachi Chemical Advanced Therapeutics Solutions (HCATS) will make clinical batches of GlaxoSmithKline’s T-cell receptor therapy targeting NY-ESO-1 from its New Jersey site.
The three-year agreement will see HCATS manufacture clinical batches of GSK’s T-cell receptor therapy targeting New York esophageal squamous cell carcinoma 1 (NY-ESO-1).
The SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell therapy is one of a number of cancer immunotherapies being codeveloped between GSK and Oxford, UK-based Adaptimmune, in a collaboration inked in 2014.
The clinical production of the T-cell therapy will take place at HCATS Allendale, New Jersey headquarters, Gregory Johnson, a spokesperson from the contract development and manufacturing organization (CDMO) told BioProcess Insider. He added the firm intends to support GSK through trials in the US, Canada and Europe.
In October 2017, HCATS announced an expansion at its New Jersey site, aimed at adding 49,700 square feet of cleanroom capacity. The expansion was deemed necessary to keep up with the high demand for cell therapy services.
Hitachi’s CDMO entry
GSK is the latest client for Hitachi.
“We are very excited about adding a global science-led healthcare industry leader to our growing list of clients, which include early cell therapy development small size, mid-size biotech and pharma and other large global biotech and pharma companies,” Johnson told us.
Hitachi entered the regenerative medicine space in 2017 through the $75 million (€66 million) acquisition of cell therapy CDMO PCT Cell Therapy Services from Caldrius Biosciences.
Under terms of the deal Hitachi/PCT continued to manufacture for Caldrius, and then in June this year acquired the rights for a Counter-Flow Centrifugation (CFC) platform from Caladrius for $2.5 million.
The CFC system, developed by Invetech, helps cell therapy developers wash and concentrate cells in an enclosed environment, and is designed for use for concentration/volume reduction, cell washing, media exchange, particle depletion and short-term incubation.