Orchard Therapeutics (“Orchard”), a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, today announced the opening of a second facility for technical operations in the San Francisco Bay Area.
In combination with the existing Foster City site, the new facility located at 1360 O’Brien Drive, Menlo Park, Calif., quadruples Orchard’s 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, Ph.D., chief manufacturing officer of Orchard, said:
Since the start of its technical operations in April 2016, Orchard has made significant 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 Operations.” Dr Craig added that “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. The Company’s 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).
Mark Rothera, president and chief executive officer of Orchard, added:
The new facility in Menlo Park reflects the rapid growth of our pipeline of transformative gene therapies. In concert with our facility expansion, we look forward to continuing to attract first class technical and management talent to the many career opportunities we are creating in our California operation.