The 150,000 square-foot facility for gene therapy manufacturing will significantly increase Orchard Therapeutics’ footprint in California.
The Fremont site will provide additional current good manufacturing practice (cGMP) manufacturing capacity for lentiviral vector and cryopreserved cell therapy products. Through this increased capacity, Orchard will be able to manufacture and deliver gene-corrected hematopoietic stem cells for a wide range of diseases to the global market.
A spokesperson from Orchard told us, “This new facility, as an early investment in our own manufacturing, will not only drive efficiencies and scalability.”
The spokesperson further explained, “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.”
Orchard stated that the new manufacturing facility will increase capacity for the long-term supply of the company’s pipeline for its advanced clinical programs.
The spokesperson told us that Orchard expects to use approximately $80-90m (€70.4-79m) in net proceeds from its recent IPO to fund the design and construction of the facility. However, the spokesperson added that these costs do not include the cost needed to operate the site.
Orchard already has two California sites, one in Foster City and the other in Menlo Park – those two sites oversee the development and validation of the manufacturing of Orchard’s ex vivo product candidates.
Building of the new site is expected to begin in 2019, and the company expects to hire more than 100 full-time employees to support in-house manufacturing.
