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Orchard Therapeutics hits up Hitachi CDMO to make autologous gene therapy – BioPharma-Reporter.com

June 6th, 2017 11:46 pm

By Staff ReporterStaff Reporter , 06-Jun-20172017-06-06T00:00:00Z Last updated on 06-Jun-2017 at 10:36 GMT2017-06-06T10:36:21Z

Hitachi Group subsidiary PCT Cell Therapy Services will provide clinical manufacturing services for Orchards autologous gene therapy for the treatment of adenosine deaminase deficiency.

Under terms of the deal, PCT will make clinical supplies of OTL-101, an autologous ex-vivo gene therapy for the treatment of adenosine deaminase deficiency severe combined immunodeficiency (ADA-SCID).

The Manufacturing Services Agreement (MSA) is an extension of a previous contract between the UK-based Orchard Therapeutics and its contract development and manufacturing organisation (CDMO).

We are very pleased to extend our relationship with PCT into a full GMP manufacturing services agreement for OTL-101, Orchards chief manufacturing officer Stewart Craig said in a statement.

As a world-leading CDMO for cell-based therapeutic products, this is an important step in advancing our lead program for the treatment of children afflicted with ADA-SCID.

PCTs CEO Robert Preti added the expansion will now include clinical manufacturing in support of [Orchards] ADA-SCID gene therapy is testament to our successful collaboration and our dedicated stewardship of this important program.

The clinical results are cause for hope among this patient population and we look forward to helping advance this important new therapeutic towards commercialisation.

The deal comes after Orchard announced it had contracted Dutch CMO PharmaCell to manufacture products from its gene therapy pipeline earlier this year, and seven months after the firm inked an alliance with gene and cell therapy firm Oxford BioMedica for process development services and cGMP-grade manufacture of lentiviral vectors.

Orchard did not supply further information when contacted by this publication.

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Orchard Therapeutics hits up Hitachi CDMO to make autologous gene therapy - BioPharma-Reporter.com

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