Safi Biotherapeutics
Developer and manufacturer of adult stem-cell derived human red blood cells (mRBCs) intended for transfusion. Focus areas include GMP biomanufacturing at clinical scale, formulation and preservation methods for long-term storage, IND-enabling regulatory work, and development of deployable manufacturing concepts for civilian and military use.
Industries
Nr. of Employees
small (1-50)
Products
Manufactured red blood cells (mRBCs)
Human red blood cells produced from adult stem cells intended as a transfusion biologic product with defined characterization and quality attributes.
adult stem-cell derived, human red blood cells (mRBCs)
Manufactured adult stem-cell derived human red blood cells designed as a highly characterized cell therapy blood transfusion product at industrial scale for civilian and military transfusion needs.
Manufactured red blood cells (mRBCs)
Human red blood cells produced from adult stem cells intended as a transfusion biologic product with defined characterization and quality attributes.
adult stem-cell derived, human red blood cells (mRBCs)
Manufactured adult stem-cell derived human red blood cells designed as a highly characterized cell therapy blood transfusion product at industrial scale for civilian and military transfusion needs.
Services
GMP production of manufactured red blood cells at clinical 10 L scale bioreactors for use in clinical studies.
R&D services to develop cryopreservation and freeze-drying formulations and processes to improve storage stability and transportability of cellular products.
Process optimization, scale-up support and technical transfer services for multi-liter cell manufacturing systems.
GMP production of manufactured red blood cells at clinical 10 L scale bioreactors for use in clinical studies.
R&D services to develop cryopreservation and freeze-drying formulations and processes to improve storage stability and transportability of cellular products.
Process optimization, scale-up support and technical transfer services for multi-liter cell manufacturing systems.
Expertise Areas
- Red blood cell biomanufacturing
- Cell therapy process development and scale-up
- GMP clinical manufacturing
- Cryopreservation and lyophilization for cell products
Key Technologies
- Adult stem-cell differentiation to red blood cells
- Stirred-tank and bioreactor cell culture (10 L scale)
- GMP bioprocessing
- Cryopreservation methods and lyophilization
News & Updates
Media coverage describing the company’s work growing red blood cells as an alternative to donated blood.
Announcement of completion of technical transfer of a 10 L clinical-scale manufactured red blood cell production system.
Received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for use in chronic transfusion of patients with sickle cell disease.
Received an NIH STTR grant to improve blood transfusion safety.
Received additional non-dilutive funding from a U.S. defense agency to advance cryogenic storage optimization for manufactured red blood cells.
Secured seed funding to accelerate development of manufactured blood for acute and chronic transfusions.
Media coverage describing the company’s work growing red blood cells as an alternative to donated blood.
Announcement of completion of technical transfer of a 10 L clinical-scale manufactured red blood cell production system.
Received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for use in chronic transfusion of patients with sickle cell disease.
Received an NIH STTR grant to improve blood transfusion safety.
Received additional non-dilutive funding from a U.S. defense agency to advance cryogenic storage optimization for manufactured red blood cells.
Secured seed funding to accelerate development of manufactured blood for acute and chronic transfusions.