Orchard Therapeutics has signed a long-term lease agreement to build-out a gene therapy manufacturing facility in Fremont, California.
The new 150,000-square-foot facility significantly increases Orchard’s footprint in California and adds to the 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 significant additional CGMP manufacturing capacity for both lentiviral vector and cryopreserved cell therapy products, enhancing Orchard’s ability to manufacture and deliver gene-corrected hematopoietic stem cells for a wide range of diseases on a global basis.
“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 Chief Manufacturing Officer Stewart Craig.
“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.