Orchard Therapeutics Opens Gene Therapy Laboratory Facility

Orchard Therapeutics has opened a second facility for technical operations at Menlo Park, CA in the San Francisco Bay Area, the company announced on Nov. 30, 2017. The new facility, in combination with an existing site at Foster City, CA, quadruples the company’s laboratory footprint for technical operations that support the development and validation of processes and controls for the manufacture of the company’s ex-vivo lentiviral gene therapy products. 

“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,” said Stewart Craig, PhD, chief manufacturing officer of Orchard, in a company press release.

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.”

The company’s pipeline includes transformative clinical and preclinical-stage autologous, ex-vivo lentiviral gene therapies. These therapies are being developed for treating primary immune deficiencies and inherited metabolic disorders. The company’s lead product, OTL-101, for treating adenosine deaminase severe combined immunodeficiency, is in late-stage development. The company expects to file a biological license application for it with FDA in 2018. The development program for this lead candidate is funded by a $19 million award from the California Institute for Regenerative Medicine.