This facility will support the late-stage clinical development and commercialization of Orca Bio’s 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.
Precision cell tech
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.