The opening of a second facility at its site in Menlo Park, California will support Orchard’s pipeline, which includes lead candidate OTL-101, a gene therapy for adenosine deaminase severe combined immunodeficiency (ADA-SCID) – a rare inherited disorder of the immune system.
“As an extension of our current Foster City operation, the Menlo Park facility will house the cell therapy and analytical operations groups developing and validating the processes and controls used for manufacture of our ex vivo lentiviral gene therapy products,” spokesperson Sylvie Blanchier told Biopharma-Reporter.
The firm’s tech platform revolves around genetically correcting stem cells taken from the patient using a lentiviral vector carrying a functioning copy of the faulty gene, and then transplanting them back into the body by IV infusion.
In November last year, Orchard inked an alliance with gene and cell therapy firm Oxford BioMedica for process development services and cGMP-grade manufacture of lentiviral vectors.
The firm has also contracted PharmaCell – since acquired by Lonza – in January, and fellow contract manufacturing organisation (CMO) PCT Cell Therapy Services in July to carry out manufacturing services for OTL-101 and its other gene therapy candidates.
The expansion of its in-house capabilities will not affect Orchard’s ongoing partnerships with these firms, Blanchier confirmed.
“Our CMO partnerships with PCT Cell Therapy Services and Lonza – for drug product manufacturing – and Oxford Biomedica continue under the existing collaboration agreements.”
Orchard hopes to file a Biological License Applicationfor OTL-101 with the US Food and Drug Administration (FDA) in 2018.