Safi Biotherapeutics and ARMI | BioFabUSA Complete Successful Technical Transfer of Initial Clinical Scale 10L mRBC Production System

Critical milestone toward transitioning Safi manufactured human red blood cells (mRBCs) to GMP manufacturing at a clinically meaningful scale

CAMBRIDGE, Mass. and MANCHESTER, N.H., Jan. 8, 2026 /PRNewswire/ -- Safi Biotherapeutics, a biotech company producing stem-cell derived, manufactured human red blood cells (mRBCs) as a dual-use product for civilian and military transfusion needs, and ARMI | BioFabUSA, a non-profit organization and a U.S. Department of War Manufacturing Innovation Institute, today announced the successful technical transfer of Safi's 10-liter scale mRBC production system. This historic achievement represents a critical step toward producing Safi mRBCs at clinically meaningful scale and meeting regulatory manufacturing requirements to address blood supply needs in both military and civilian settings, including support for combat trauma as well as patients living with sickle cell anemia, cancer, or other transfusion-dependent conditions.

"The successful transfer of our 10-liter bioreactor mRBC production system to our manufacturing partner ARMI | BioFabUSA positions Safi to manufacture human mRBCs at clinically meaningful scale and GMP-ready, regulatory conditions. We are committed to an initial IND submission in 2027 for use of our mRBCs in sickle cell disease chronic transfusion therapy," said Doug McConnell, Chief Executive Officer and Co-Founder of Safi Biotherapeutics. "This also puts us on a path to expand into clinical studies for surgical and trauma-related acute blood loss. This achievement would not have been possible without the expertise and close collaboration with the team at ARMI | BioFabUSA."

"Safi Biotherapeutics is a bold and steadfast pioneer in the development of next-generation blood products, and ARMI | BioFabUSA is deeply proud to serve as Safi's manufacturing partner," said Jennifer MacDonald, MD, Chief Operating Officer of ARMI | BioFabUSA. "This milestone demonstrates a clear technical vision for the scalable, consistent, cost-effective manufacture of critical blood products that will save the lives of warfighters and the public."

About Safi Biotherapeutics

Safi Biotherapeutics produces stem-cell derived, human RBCs with the goal of providing a highly characterized cell therapy product at industrial scale and viable economics for civilian and military transfusion needs. Safi's manufacturing blueprint for RBC production is the most advanced in the industry, and the company's readily addressable markets include chronic transfusion indications such as sickle-cell disease (SCD) and acute transfusion settings such as civilian and military hospitals during critical times of need. Safi leadership, comprised of industry and cell therapy veterans from DARPA, Vertex Pharmaceuticals, and Loughborough University in the United Kingdom, launched the company in 2020 as part of the U.S. Department of Defense On-Demand Blood program. Safi's mRBC product has been granted U.S. FDA Rare Pediatric Disease Designation and Orphan Drug Designation for use in chronic transfusion of patients with SCD.

For more information on Safi, visit: https://safi.bio/ or follow us on LinkedIn.

About ARMI | BioFabUSA

The Advanced Regenerative Manufacturing Institute (ARMI) I BioFabUSA is a Member-based non-profit organization and U.S. Department of War Manufacturing Innovation Institute devoted to advancing the U.S. bioeconomy and transforming the future of human health. Launched in 2017 with a foundational investment from the U.S. Government, ARMI | BioFabUSA operates at the intersection of biomedical technology and automated manufacturing, convening a dynamic, purpose-built network of hundreds of industry, academic, and civic collaborators to drive the leading edge of biomedical innovation. By providing wrap-around manufacturing, technical, and commercialization services to the bioinnovation industrial base, ARMI | BioFabUSA powers the scalable, consistent, cost-effective manufacture of next-generation biomedical products – de-risking the path to market and enabling life-saving therapeutics to reach patients.

Safi Contact:

Doug McConnell
[email protected]

ARMI | BioFabUSA Contact:
Jennifer MacDonald
[email protected]

Media Inquiries:
David Rosen, Argot Partners
[email protected]
212-600-1902

SOURCE Safi Biotherapeutics