Collaboration to support Safi IND data package for use of mRBCs in sickle cell disease chronic transfusions
Safi Biotherapeutics, a biotechnology company producing stem-cell derived, manufactured human red blood cell (mRBC) products for civilian and military transfusion needs, and Functional Fluidics, a leader in red blood cell health innovation, announced a collaboration focused on validating the health and quality of Safi’s mRBCs to enable Safi to prepare a comprehensive in vitro pre-clinical data package in support of an IND submission for use of its mRBCs in sickle cell disease (SCD) chronic transfusion therapy.
In December 2024, the FDA granted Safi’s mRBC product Rare Pediatric Disease Designation and Orphan Drug Designation for use in chronic transfusion of patients with SCD.
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“Functional Fluidics is a precision diagnostics company pioneering the field of red blood cell health, and their successful track record validating many high-profile therapies makes them an ideal partner as we prepare an IND submission using Safi mRBCs for those sickle cell patients who require regular, often monthly, transfusions of RBCs,” said Doug McConnell, CEO and Co-Founder of Safi Biotherapeutics. “There is a critical need for readily available and appropriately matched blood supply for this patient population, and our collaboration is a key step toward delivering a safe and reliable blood product. We are very happy to be working with the team at Functional Fluidics.”
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“Patients with sickle cell disease who rely on chronic transfusion therapy face significant challenges, particularly the high risk of alloimmunization. As the leader in its field, Safi has developed an innovative approach to producing mRBCs with targeted cell surface antigen profiles to provide chronically transfused patients with a safe and reliable supply of blood,” said Patrick Hines, M.D., Ph.D., Founder and CEO of Functional Fluidics. “We are uniquely positioned to support Safi’s development efforts through our expertise in large-scale RBC validation and are excited to collaborate to help improve outcomes for people living with sickle cell disease around the world.”
While Safi is initially focused on bringing mRBCs to patients for chronic transfusions in such diseases as SCD, its mRBCs also have the potential to meet the need for an extended supply of universal-donor RBC units for acute blood loss in military and civilian settings. In February 2025, Safi announced a collaboration with ARMI | BioFabUSA, a non-profit organization and Department of Defense Manufacturing Innovation Institute, focused on transitioning Safi mRBCs to cGMP manufacturing at a clinically meaningful scale.
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Source – PR Newswire
