Biotech firm expands technical ops

Orchard Therapeutics, a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, has announced the opening of a second facility for technical operations in the San Francisco Bay Area of California, USA.

In combination with the existing Foster City site, the new facility quadruples Orchard¹s laboratory footprint for the technical operations that support development and validation of processes and controls for the manufacture of the company's ex-vivo lentiviral gene therapy products.

Stewart Craig, chief manufacturing officer of Orchard, said, "Since the start of its technical operations in April 2016, Orchard has made progress in building a world-class team of experts for the development, manufacture and delivery of our ex-vivo gene therapy product pipeline. Opening of the new Menlo Park facility represents the next step of a phased plan to establish a fully integrated infrastructure for the company's technical opertaions. Even as we open the new Menlo Park site, we are already evaluating sites for a further custom-built facility in the Bay area to provide another threefold increase in our overall capacity with additional operational capabilities by 2019."

Orchard's pipeline includes transformative clinical and pre-clinical stage autologous, ex-vivo lentiviral gene therapies for primary immune deficiencies and inherited metabolic disorders. Its lead product, OTL-101, for the treatment of adenosine deaminase severe combined immunodeficiency (ADA-SCID) is in late-stage development and is anticipated to progress to a Biological License Application with the FDA in 2018. The OTL-101 development program has received a $19 million award from the California Institute for Regenerative Medicine (CIRM).

Recent Issues