- Orchard Therapeutics on Thursday announced it would build a 150,000-square-foot facility in Fremont, California, for manufacturing of gene therapies after signing a long-term lease agreement on the site.
- Work should begin next year, and more than 100 full-time employees will likely be hired over coming years as in-house manufacturing ramps up, Orchard said in a statement.
- The facility will give Orchard capacity for manufacturing lentiviral vectors, which are used to deliver gene therapies, and cryopreserved cell therapy products. Orchard says it will also continue working with contract manufacturing partners as it continues to develop its pipeline of therapeutic candidates.
Orchard is taking a bet on its own manufacturing abilities as it works to bring more gene therapy products to market for rare diseases.
The company acquired GlaxoSmithKline's gene therapy portfolio earlier this year, including Strimvelis, a treatment approved in Europe to treat the immune deficiency known as ADA-SCID, sometimes called "bubble-boy disease." In the deal, GSK agreed to keep conducting some clinical activities as part of a transition period through the end of this year.
The facility may help Orchard overcome a sticking point in gene therapy development: the manufacture of viral vectors to deliver the DNA-altering therapies. Even as the gene therapy field shows increasing promise, biopharmaceutical companies have encountered a shortage in supply of the disabled viruses needed to effectively deliver their treatments into cells.
"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," Orchard's chief manufacturing officer, Stewart Craig, said in the company's statement.
Orchard also has its own treatment for ADA-SCID in advanced studies and is developing therapies for metachromatic leukodystrophy, Wiskott-Aldrich syndrome, X-linked chronic granulomatous disease and transfusion dependent beta-thalassemia, among other disorders.
The new facility is part of Orchard's larger strategy to reduce production expenses, which can be high for complex gene therapies. The company is also working to improve efficiency in manufacturing, including plans for some automation in the production line.