Orchard Therapeutics has entered a clinical manufacturing services agreement with PCT Cell Therapy Services, a provider of contract services for the development and manufacture of cell-based therapeutic and regenerative medicine products. PCT has previously provided a strategic manufacturing assessment (SMA) and manufacturing process development services to Orchard. 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).

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

To date, over 40 ADA-SCID patients have been treated with Orchard’s autologous ex-vivo lentiviral gene therapy at University of California Los Angeles (UCLA), and at the Great Ormond Street Hospital (GOSH) in London, UK.

Robert Preti, chief executive officer and president, PCT, said, “Expansion of our agreement with Orchard to now include clinical manufacturing in support of their 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 commercialization.”