Safi Biotherapeutics Collaborates with Functional Fluidics
Safi Biotherapeutics, a pioneering biotechnology firm, has announced a partnership with Functional Fluidics, a leader in red blood cell health technology. Together, they aim to validate the health and quality of Safi's manufactured red blood cell (mRBC) products. This collaboration is particularly significant as it focuses on preparing a comprehensive data package to support an Investigational New Drug (IND) application.
Supporting Sickle Cell Disease Treatment
This collaboration comes in the wake of Safi's mRBC product receiving the Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for chronic transfusion in patients suffering from sickle cell disease (SCD). The use of mRBCs is crucial as it offers a solution to a well-recognized issue: the scarcity of appropriately matched blood for patients who frequently require transfusions.
Doug McConnell, CEO and Co-Founder of Safi Biotherapeutics, emphasized the collaboration's importance by stating, "We are faced with a critical need for a reliable blood supply for sickle cell patients. Working with Functional Fluidics will aid us in ensuring that we can deliver a safe blood product tailored to meet these needs."
The Unique Challenges of Chronic Transfusion Therapy
For patients with sickle cell disease necessitating ongoing transfusion therapy, challenges are predominant. One major hurdle is the risk of alloimmunization, where a patient's immune system begins to reject transfused blood due to the introduction of foreign antigens. By creating mRBCs with specific cell surface antigen profiles, Safi aims to deliver a blood supply that not only meets these challenges but also enhances patient safety and outcomes.
Patrick Hines, M.D., Ph.D., CEO of Functional Fluidics, expressed mutual excitement about this collaboration: "We are well-positioned to support Safi's development through our extensive validation expertise in large-scale RBC manufacturing. Together, we can work to improve the quality of life for patients with sickle cell disease globally."
Multiple Applications for mRBCs
Although the immediate focus is on supporting chronic transfusions for sickle cell disease, Safi’s mRBC technology also holds promise for military and civilian applications. There is a budding demand for universal-donor blood units in acute situations, which may serve in combat or emergency room settings.
Earlier this year, Safi also announced its partnership with ARMI | BioFabUSA, aimed at advancing the transition of mRBCs into clinically meaningful manufacturing scales to address both military and civilian needs during critical times.
Mission and Vision of Safi Biotherapeutics
Founded in 2020 as part of the U.S. Department of Defense On-Demand Blood program, Safi Biotherapeutics looks to redefine the blood product landscape by providing stem-cell derived human RBCs at an industrial scale. The leadership team, comprised of specialists from DARPA, Vertex Pharmaceuticals, and Loughborough University, reflects the company's dedication to revolutionizing transfusion therapy.
With the ever-increasing need for effective and safe transfusions in both civilian and military scenarios, Safi is poised to lead as a catalyst for change in blood product manufacturing and distribution.
For further insights into their groundbreaking work, interested parties can visit Safi’s
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