Orca Bio expands manufacturing capabilities to take cell therapies through to commercialization – BioPharma-Reporter.com

This facility will support the late-stage clinical development and commercialization of Orca Bios precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.

The new facility is located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the US. 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. It will include modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices.

The site will have the capacity to manufacture around 3,000 cell therapy products a year: thus allowing the company to scale to meet future demand and providing the critical infrastructure to enable Orca Bio to expand its pipeline.

Construction has already begun and is scheduled to be completed later this year, with the facility set to be fully validated and operational in the first half of 2023.

Orca Bio uses precision cell selection technology to identify the less than 1% of the 100 billion donor cells that potentially contain therapeutic benefits for patients. These cells are then manufactured into potentially curative cell therapies designed to maximize efficacy of treatment and significantly limit treatment-related risks.

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

At the head of its pipeline is Orca-T: which recently entered a Phase 3 study for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

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, said Ivan Dimov, Ph.D., co-founder and chief executive officer 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.

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Orca Bio expands manufacturing capabilities to take cell therapies through to commercialization - BioPharma-Reporter.com