Orchard Therapeutics announces new gene therapy manufacturing facility. A new facility in California will expand Orchard Therapeutic's capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells. Orchard Therapeutics announced in a Dec. 13, 2018 press release that it signed a long-term lease agreement to build out a gene therapy manufacturing facility in Fremont, CA. The new 150,000-ft[2] facility adds to the Foster City and Menlo Park, CA 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 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, the company also plans to continue its collaborations with its contract manufacturing partners. "The expansion of our California operations to now include a manufacturing facility is a critical step in advancing Orchard's capabilities to supply products for our ex vivo gene therapy programs," said Stewart Craig, chief manufacturing officer of Orchard Therapeutics, in the press release. "We believe that this new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability in terms of lentiviral vector and drug product development, it will also complement the capabilities of our existing vector and drug product manufacturing partners to support the potential launch of our gene therapy clinical product candidates." 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. Stay at the forefront of biopharmaceutical innovation - subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Er-Kim will collaborate with Orchard Therapeutics to refer eligible children with early-onset MLD identified in these countries to an established European-based qualified treatment center.