Rare Daily Staff
Gene therapy developer Orchard Therapeutics said it has opened a second facility for technical operations in Menlo Park, California, expanding its presence in the San Francisco Bay Area as the company’s moves closer to filing an application to market its lead experimental therapy.
The company says new facility quadruples its laboratory space for technical operations that support development and validation of processes and controls for the manufacture of the Company’s ex-vivo lentiviral gene therapy products. The company already has lab space in Foster City, California.
“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,” said Stewart Craig, chief manufacturing officer of Orchard. “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.”
More expansion plans for Orchard is in the works. The company said its evaluating sites for an additional custom-built facility in the Bay area to provide another threefold increase in its overall capacity with additional operational capabilities by 2019.
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. ADA-SCID is a rare disorder caused by a genetic mutation that prevents production of adenosine deaminase, an essential protein need to produce lymphocytes, a type of white blood cell. Children born with ADA-SCID do not develop a properly functioning immune system. As a result, they are unable to fight off everyday infections, which result in severe and life-threatening illness.
December 4, 2017