Tailored blood, at scale

Our mission is to make blood tailored for the people who need it, at scale & viable economics for broad civilian & military use

At Safi Biotherapeutics, we manufacture adult stem-cell derived, human red blood cells (mRBCs), with the goal of providing a highly characterized cell therapy blood transfusion product at industrial scale and viable economics for civilian and military transfusion needs. Blood is the most prescribed biologic therapy in the world. Blood donor supply shortages continue to be a global crisis, and we are uniquely positioned to provide a safe and reliable blood supply to meet this challenge. Our mRBCs have valuable potential use in chronic transfusion indications as well as in acute transfusion settings, such as hospitals and battlefields.

Modern & scalable biomanufacturing that meets purity & quality standards

Modern & Scalable Biomanufacturing That Meets Purity & Quality Standards

Safi’s manufacturing blueprint for red blood cell production is the most advanced in the industry. Our collaboration with ARMI | BioFabUSA, a non-profit organization and U.S. Department of War Manufacturing Innovation Institute, is supporting the GMP production of mRBCs for clinical trials. This collaboration, alongside our proprietary advanced biomanufacturing processes, enables the manufacture of units of ultra-high densities of mRBCs in 10-liter scale bioreactors that consistently meet strict purity and quality standards. GMP manufacturing for initial clinical studies at 10-liter scale is currently underway.

Advanced cryopreservation & stockpiling

We continue to advance our research of cryopreserved and freeze-dried mRBCs, which present innovative solutions across civilian and military settings, particularly with respect to pre-hospital use and government stockpiling. We have achieved proof of principle showing our mRBCs are more resistant to the detrimental effects of both cryopreservation (without glycerol) and freeze-drying. This early work provides a foundation for optimization of cell specification and formulation that maximizes product viability for long-term storage and transport.

About Safi

Founded in 2020 as the cell therapy commercialization partner of the U.S. Defense Health Agency On-Demand Blood program, Safi has received more than $20 million in non-dilutive government funding and completed a $5 million private seed investment. These investments are accelerating the GMP manufacturing of our red blood cells at clinically meaningful scale and the completion of IND-enabling activities for clinical trial initiation in 2027. In 2024, the U.S. Food and Drug Administration granted our mRBCs Rare Pediatric Disease Designation and Orphan Drug Designation for use in the chronic transfusion of patients with sickle cell disease.

Recent news featuring Safi Biotherapeutics

Safi Biotherapeutics and ARMI | BioFabUSA Complete Successful Technical Transfer of Initial Clinical Scale 10L mRBC Production System JAN. 8, 2026 Safi Biotherapeutics and Functional Fluidics Initiate Collaboration to Validate Health and Quality of Manufactured RBCs JUL. 16, 2025 Safi Biotherapeutics Awarded NIH STTR grant to Improve Blood Transfusion Safety APR. 24, 2025 U.S. DoD Awards Safi Biotherapeutics $3.5 Million in Additional Non-Dilutive Funding to Optimize Cryo-Storage of mRBCs FEB. 25, 2025 Safi Biotherapeutics and ARMI | BioFabUSA Initiate Collaboration to Support Large-Scale Development of mRBCs FEB. 10, 2025 Safi Biotherapeutics Granted Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. FDA DEC. 18, 2024 Safi Biotherapeutics Secures $5M in Seed Funding to Accelerate Plans to Grow Blood for Acute and Chronic Transfusions SEP. 11, 2024 This government-backed startup is growing blood to help fight shortages SEP. 11, 2024 Safi Biotherapeutics Solidifies Leading Position in Red Blood Cell Biomanufacturing with Acquisition of EryPharm Assets JAN. 05, 2024 Point-of-Need Manufacturing Challenge Demonstrates Technologies for Cold Weather Combat Effectiveness DEC. 15, 2023 Safi Biosolutions rebranding as Safi BiotherapeuticsAUG. 4, 2022 Safi Biosolutions developing alternatives to donated blood as part of USU 4D Bio3 On-Demand Blood programMAR. 24, 2022 iBio Enters into Agreement with Safi Biosolutions to Develop Growth Factors and Cytokines Using the FastPharming® SystemOCT. 2, 2020 nScrypt’s Research Arm Teams Up to Make Human BloodAPR. 7, 2020 Blood Shortage on the Battlefield? Just Make It On-siteFEB. 26, 2020 4D Bio3 Improves Battlefield CareFEB. 27, 2020

Team

Safi Biotherapeutics leadership comprises industry and cell therapy veterans from the Defense Advanced Research Projects Agency (DARPA), Vertex Pharmaceuticals, Mass General Brigham and Loughborough University in the United Kingdom. They bring experience in ex vivo human blood cell development, biologic and pharmaceutical manufacturing, pre-clinical and clinical development, and regulatory submissions.

Doug McConnell MBA
Doug McConnell MBACEO & Co-Founder
Prior to helping launch Safi Biotherapeutics in Q4 2019, Doug held strategic and operational leadership roles at Vertex Pharmaceuticals and Radius Health, spanning R&D, Quality, Regulatory and new product planning, supporting submission and launch of initial Vertex products INCIVEK, KALYDECO and ORKAMBI, and Radius Health’s TYLMOS. While at Vertex he also formed and led a virtual drug development unit for advancing pre-clinical stage candidates with external partners in emerging markets. Earlier in his career, Doug led strategic consulting initiatives for major Pharmaceutical and Biotech companies.
Jon Mogford PhD
Jon Mogford PhDCo-Founder
Dr. Mogford is the Vice Chancellor Research for Texas A&M System’s 11 Universities and 8 State of Texas agencies. Previously, as the DARPA/DSO Deputy Director, he spearheaded expansion of the formal working relationship between DARPA and the FDA, and was recipient of the Secretary of Defense Medal for Outstanding Public Service. As a DARPA Program manager Jon led the 2008-12 DARPA Blood Pharming program.
Kyle Meetze MBA
Kyle Meetze MBACOO
Kyle brings over 25 years of strategic and operational leadership across an array of biomedical companies, universities, and healthcare institutions. He has led and participated in dozens of licensing, fundraising, and partnering deals. Most recently, as CBO of EdenRoc Sciences, Kyle led strategic planning, budgeting and oversight of operations, finance, contracting, HR, facilities & IT for 8 start-ups.
Rob Thomas PhD
Rob Thomas PhDChief Technology Officer
Dr. Thomas has over 15 years of relevant expertise in cell development process optimization and cost reduction for pre-clinical and clinical stage manufacture processes. Prior to becoming Chief Technology Officer for Safi, Rob was the founder and Managing Director of Advanced Bioprocess Services (UK) and is a Professor of Cell and Gene Therapy Manufacture at Loughborough University.
Katie Glen PhD
Katie Glen PhDScientific Lead
Dr. Glen brings over 15 years of bioprocess research experience- including cell culture, analysis, and process development for haematopoietic progenitor expansion and differentiation, and has performed multi-liter scale up across multiple cell types. Prior to her role as Scientific Lead for Safi, Katie had operational and scientific leadership roles in the Loughborough University Centre for Biological Engineering and Advanced Bioprocess Services.