Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, is establishing operations at Metro Air Park in Sacramento, California.
The new 100,000-square-foot commercial facility will support the late-stage clinical development and commercialization of the company’s precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.
“The new state-of-the-art facility represents critical infrastructure to enable the advancement of our pipeline and the future commercial availability of our potentially life-saving products,” said Jeroen Bekaert, Ph.D., co-founder and chief operating officer of Orca Bio. “With the capacity to manufacture approximately 3,000 cell therapy products per year, the facility will allow us to scale to meet future demand. Investing in our manufacturing capabilities is essential to our mission of delivering a cure without compromise while ensuring timely access to the patients who need it, when they need it.”
Construction began in August of 2021 and is scheduled to be completed later this year. The facility is expected to be fully validated and operational in the first half of 2023.
“Throughout the clinical development of our products, we have demonstrated the ability to reliably manufacture and deliver high-precision cell therapies with rapid turnaround times, regardless of donor and patient location,” added Ivan Dimov, Ph.D., co-founder and CEO of Orca Bio. “This new facility will further enhance our capabilities to deliver our therapies urgently and seamlessly to patients at scale, while meeting the highest quality and regulatory standards.”
The facility is strategically located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the U.S. It is also in close proximity to Orca Bio's existing clinical manufacturing building. The facility is uniquely tailored to manufacture precision cell therapies designed to replace cancerous blood and immune systems with healthy ones.