An integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare diseases through innovative gene therapies, Orchard Therapeutics has revealed its plans to build-out a gene therapy manufacturing facility in Fremont, California.
The new 150,000-square-foot facility will significantly increase Orchard’s California footprint 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 haematopoietic stem cells for a wide range of diseases on a global basis. In addition to this expanded capacity, Orchard also plans to continue its close collaborations with the Company’s 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,” explained Stewart Craig, PhD Chief Manufacturing Officer.
“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.
“Orchard’s new California manufacturing facility will provide enhanced capacity and long-term supply in support of our extensive pipeline beyond the Company’s most advanced clinical programs,” added Mark Rothera, President and Chief Executive Officer, Orchard. “We are pleased to continue our growth in the Bay Area and look forward to welcoming additional technical and management talent to join our mission of transforming patient’s lives through gene therapy.”
Orchard’s portfolio of autologous ex vivo gene therapies includes Strimvelis, acquired from GlaxoSmithKline earlier this year. It is the first autologous ex vivo gene therapy approved by the European Medicines Agency for adenosine deaminase severe combined immunodeficiency (ADA-SCID), which is widely known as ‘bubble-boy’ disease.
Additional programmes for primary immune deficiencies, neurometabolic disorders and hemoglobinopathies include three advanced registrational studies for ADA-SCID, metachromatic leukodystrophy (MLD) and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD) and transfusion dependent beta-thalassemia (TDBT), as well as an extensive preclinical pipeline.
Orchard currently has offices in the UK. and the US., including London, San Francisco and Boston.