Hitachi CDMO Signs Gene Therapy Manufacturing Pact

Orchard Therapeutics Limited, a clinical-stage biotechnology company, has entered a new clinical manufacturing services agreement with PCT Cell Therapy Services, LLC a Hitachi Group Company and contract development and manufacturing organization of cell-based therapeutic and regenerative medicine products.

PCT previously provided a strategic manufacturing assessment (SMA) and manufacturing process development services to Orchard. Under the terms of this new agreement, PCT will provide GMP-compliant manufacturing services for Orchard’s lead product, OTL-101, an autologous ex-vivo gene therapy for the treatment of adenosine deaminase deficiency severe combined immunodeficiency (ADA-SCID). ADA-SCID is a rare inherited disorder of the immune system caused by mutations in the gene encoding for the enzyme adenosine deaminase, which result in a deficiency in white blood cells and infections.

In May 2017, Caladrius Biosciences, a clinical-stage development company with a cell therapy pipeline, closed on the sale of its remaining 80.1% ownership interest in its PCT subsidiary to Hitachi Chemical Co. America, Ltd. for $75 million, subject to certain adjustments, including based on PCT’s cash and outstanding indebtedness as of the closing date and a potential future milestone payment. With the acquisition, PCT became an independent business unit focused on cell therapy and regenerative medicine within the life sciences division of Hitachi Chemical.

In October 2016, Hitachi Chemical announced its investment of approximately $17.5 million in establishing a new contract development and manufacturing facility for regenerative medicine cells and other products in Yokohama, Japan. The facility will begin full operation in April 2018. This and other PCT locations will share the same global platform for quality and information systems, manufacturing operations, and technology transfer protocols,

Source; PCT Cell Therapy Services

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