Orchard Therapeutics To Build New Gene-Therapy Mfg Facility in CaliforniaBy
Orchard Therapeutics, a Foster City, California-based clinical-stage biotechnology company, has signed a lease agreement to build-out a gene-therapy manufacturing facility in Fremont, California.
The new 150,000-square-foot facility adds to Orchard’s Foster City and Menlo Park, California sites, which oversee the ongoing development and validation of the manufacture of Orchard’s ex vivo gene-therapy product candidates.
Once operational, the new site will provide additional CGMP manufacturing capacity for both lentiviral vector and cryopreserved cell-therapy products, enhancing Orchard’s ability to manufacture and deliver gene-corrected hematopoetic stem cells for a range of diseases on a global basis. In addition to this expanded capacity, Orchard said it also plans to continue its close collaborations with the company’s contract manufacturing partners.
The build-out of Orchard’s new manufacturing facility is expected to begin in 2019, and the company expects to hire more than 100 full-time employees over the next few years to support in-house manufacturing efforts.
Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID). Additional programs for primary immune deficiencies, neurometabolic disorders and hemoglobinopathies include three advanced registrational studies for ADA-SCID, metachromatic leukodystrophy and Wiskott-Aldrich syndrome, clinical programs for X-linked chronic granulomatous disease and transfusion dependent beta-thalassemia, as well as an extensive preclinical pipeline.
Orchard currently has offices in the UK and the US, including London, San Francisco, and Boston.
Source: Orchard Therapeutics