Safi Biosolutions
Safi Biotherapeutics is a pre-revenue clinical-stage biotech that manufactures adult stem-cell derived red blood cells (mRBCs) at 10-liter GMP scale for civilian hospitals, military medical supply chains, and chronic transfusion patients, with FDA Orphan and Rare Pediatric Disease designations in sickle cell disease and clinical trials targeted for 2027.
- Company typePrivate
- Founded2020
- HeadquartersArlington, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Safi Biosolutions does
Safi Biotherapeutics (formerly Safi Biosolutions, rebranded August 2022) is a pre-revenue, clinical-stage cell therapy company headquartered in Cambridge, Massachusetts. The company manufactures adult stem-cell derived human red blood cells (mRBCs) using proprietary biomanufacturing processes operated at 10-liter GMP-compliant bioreactor scale. Its product portfolio centers on a core mRBC transfusion product, with variants under development including cryopreserved (glycerol-free) mRBCs, freeze-dried mRBCs in collaboration with DesiCorp, and iPSC-derived RBCs with rare antigen profiles developed with CHOP under an NIH STTR grant for sickle cell disease and alloimmunized patients.
Safi was founded in 2020 as the cell therapy commercialization partner of the U.S. Defense Health Agency On-Demand Blood program, and its development priorities remain tightly aligned with U.S. military and civilian transfusion needs. The company has secured more than $20M in non-dilutive government funding from the DHA, DoD, and NIH, supplemented by a $5M seed round led by J2 Ventures in September 2024. In January 2024, Safi acquired EryPharm assets to consolidate manufacturing IP, and in December 2024 the FDA granted both Rare Pediatric Disease Designation and Orphan Drug Designation for chronic transfusion of sickle cell disease patients. GMP manufacturing for initial clinical studies is underway, with IND-enabling activities and clinical trial initiation targeted for 2027.
The commercial model is product sales of a regulated cell therapy biologic to civilian hospitals, military medical supply chains, and chronic transfusion patients, with hospital procurement and government stockpiling as the expected distribution pathways. Pre-revenue status is explicit; pricing has not been disclosed and will depend on regulatory approval, indication, and reimbursement dynamics for a novel ex vivo manufactured blood product.
Safi Biosolutions firmographics
Firmographics- Name
- Safi Biosolutions
- Legal name
- Safi Biotherapeutics, Inc.
- Website
- https://safi.bio
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Safi Biotherapeutics is a pre-revenue clinical-stage biotech that manufactures adult stem-cell derived red blood cells (mRBCs) at 10-liter GMP scale for civilian hospitals, military medical supply chains, and chronic transfusion patients, with FDA Orphan and Rare Pediatric Disease designations in sickle cell disease and clinical trials targeted for 2027.
- Ownership category
- akta.pro rank
Safi Biosolutions industry classification
Industry- Product category
- Cell Therapy Biologics
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE)
- akta.pro secondary industries
- Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC), Cell Therapy Manufacturing Platforms & Automation (closed systems, bioreactors, fill-finish) (HLAAABAG), Transfusion Medicine & Immunohematology (Blood Bank) (HLAFAMAG)
Keywords
Where Safi Biosolutions is headquartered
LocationHeadquarters
- HQ city
- Arlington
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Safi Biosolutions business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure, Supply Chain
Revenue model
- mRBC Biologic Product Sales: Pre-revenue. The company is developing a cell therapy blood transfusion product (mRBCs) intended for sale to civilian hospitals, military medical supply chains, and chronic transfusion patients. GMP manufacturing is underway with clinical trial initiation targeted for 2027. Revenue generation is expected through product sales upon regulatory approval.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels3 records
Safi Biosolutions product offering
Product offeringCore offering
Safi Biosolutions (operating as Safi Biotherapeutics) manufactures adult stem-cell derived human red blood cells (mRBCs) at industrial scale using proprietary biomanufacturing processes in 10-liter GMP bioreactors. The company develops these cell therapy blood transfusion products for civilian hospitals, military medical needs, and chronic transfusion patients such as those with sickle cell disease, with specialized variants including cryopreserved and freeze-dried formulations.
Product overview
Safi Biotherapeutics operates as a single-product biomanufacturing company producing manufactured red blood cells (mRBCs) as a cell therapy blood transfusion product. The core offering consists of adult stem-cell/iPSC-derived red blood cells produced at 10-liter scale bioreactors using proprietary biomanufacturing processes. The product portfolio includes the foundational mRBC product, specialized iPSC-derived RBCs with rare antigen profiles for sickle cell disease patients, and advanced formulations including freeze-dried and cryopreserved variants developed through collaborations with DesiCorp and others. The company is pursuing GMP manufacturing for clinical trials with IND-enabling activities underway for a 2027 trial initiation.
Differentiator
Problem solved
Functional benefit
Products and services
- mRBCs (manufactured Red Blood Cells)
Quantifiable outcome
- GMP manufacturing for initial clinical studies at 10-liter scale is currently underway, with clinical trial initiation targeted for 2027.
- +2 more outcomes
Companies that use Safi Biosolutions
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles3 records
Safi Biosolutions technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Safi Biosolutions partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and supporting.
- DesiCorp Inc.coreCollaboration to develop freeze-dried human red blood cells (mRBCs) for portable, shelf-stable transfusions. The partnership aims to address critical shortages in blood supply and expand access to life-saving transfusions outside traditional hospitals. This addresses pre-hospital and government stockpiling use cases.
- Functional FluidicssupportingCollaboration to validate the health and quality of manufactured red blood cells. This partnership generates proprietary quality characterization data supporting regulatory submissions and product development.
- Children's Hospital of Philadelphia (CHOP)coreNIH STTR-funded collaboration with CHOP to develop scalable production of iPSC-derived red blood cells with rare antigen profiles. The project aims to create blood banking reagents for better donor compatibility, especially for patients with sickle cell disease and those who are alloimmunized. This research supports both civilian and military medical transfusion needs.
- ARMI | BioFabUSAcoreCollaboration with ARMI | BioFabUSA, a non-profit U.S. Department of War Manufacturing Innovation Institute, to support large-scale development and GMP production of mRBCs for clinical trials. The organizations completed a successful technical transfer of the initial clinical-scale 10L mRBC production system in January 2026. This partnership is central to Safi's manufacturing strategy.
- EryPharmcoreAcquisition of EryPharm assets solidified Safi's leading position in red blood cell biomanufacturing. This asset acquisition expanded the company's manufacturing IP, processes, and capabilities, strengthening its competitive moat in the sector.
- U.S. Defense Health Agency — On-Demand Blood ProgramcoreSafi was founded in 2020 as the cell therapy commercialization partner of the U.S. Defense Health Agency On-Demand Blood program. This foundational government partnership has provided over $20M in non-dilutive funding and drives the company's military medical transfusion product development.
Scale indicators7 records
Recent moves7 records
Expansion highlights6 records
Safi Biosolutions competitors and assessment
Company assessmentDirect peers
- Rubius Therapeutics: Developed engineered red blood cell (RBC) therapeutics as a cell therapy platform, directly comparable to Safi's approach of manufacturing RBC-based cellular products for therapeutic use. Both companies share the core thesis that lab-grown/ engineered RBCs can address transfusion and rare disease indications.
- KaloCyte: Developer of ErythroMer, a bioengineered red blood cell substitute designed for pre-hospital and battlefield transfusion use cases. Directly comparable to Safi's mRBC platform on target use case (military/civilian emergency transfusion) and product category (manufactured RBC product).
- Cellphire Therapeutics: Developer of Thrombosomes, a lyophilized platelet substitute designed for transfusion use, with a similar "manufactured blood product" business model. Comparable to Safi's manufactured mRBCs as a non-donor-derived transfusion product with extended shelf life.
Emerging players
- Hemarina: Developer of HEMO2life, an oxygen-carrying therapeutic derived from marine worm hemoglobin, focused on organ preservation and transfusion-adjacent indications. Comparable as an emerging alternative to donated blood for transfusion applications.
Broad incumbents
- Vertex Pharmaceuticals: Large biotech that launched CASGEVY (exa-cel) for sickle cell disease with CRISPR Therapeutics, representing a competing therapeutic approach to chronic SCD transfusions. Comparable as a strategic adjacent player in the sickle cell treatment landscape that Safi's mRBCs also target.
- bluebird bio: Gene therapy company developing lovotibeglogene autotemcel (lovo-cel) for sickle cell disease, a competing approach to chronic SCD management. Comparable as a SCD therapeutic that addresses the same patient population Safi's chronic transfusion indication targets.
- Octapharma: Global manufacturer of plasma-derived and recombinant blood products serving hospital transfusion customers worldwide. Comparable as a broad incumbent in the blood/biologic transfusion market that Safi will need to displace or partner with for hospital adoption.
- CSL Behring: Global plasma and blood products company with an extensive hospital transfusion portfolio. Comparable as a broad incumbent supplier of transfusion products whose established hospital procurement relationships will shape Safi's commercial pathway.
- American Red Cross: Largest U.S. blood collection and distribution organization, supplying the majority of donated blood products to civilian hospitals. Comparable as the dominant incumbent Safi's mRBCs are positioned to displace in the transfusion supply chain.
Others
- ARMI | BioFabUSA: U.S. Department of War Manufacturing Innovation Institute providing GMP biomanufacturing infrastructure and technical transfer for cell and tissue-based therapies. Comparable as a key manufacturing/ecosystem partner to Safi and an enabling infrastructure provider for cell therapy scale-up.
Market position
Weaknesses5 records
Competitive moat6 records
Key risks7 records
Key highlights7 records
Customer concentration
Safi Biosolutions social profiles
Digital presenceSafi Biosolutions financial estimates
Financial estimateRevenue estimate
Valuation estimate
Safi Biosolutions leadership team
Management profileNumber of profiles
Profiles5 records
Safi Biosolutions funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Safi Biosolutions M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Safi Biosolutions
What does Safi Biosolutions do?
Safi Biosolutions (operating as Safi Biotherapeutics) manufactures adult stem-cell derived human red blood cells (mRBCs) at industrial scale using proprietary biomanufacturing processes in 10-liter GMP bioreactors. The company develops these cell therapy blood transfusion products for civilian hospitals, military medical needs, and chronic transfusion patients such as those with sickle cell disease, with specialized variants including cryopreserved and freeze-dried formulations.
Is Safi Biosolutions a public or private company?
Safi Biosolutions is a private company. It is classified as venture growth investor backed and is currently operating.
When was Safi Biosolutions founded?
Safi Biosolutions was founded in 2020. It employs 11 to 50 people.
Where is Safi Biosolutions based?
Safi Biosolutions is headquartered in Arlington, United States, in the North America region.
How does Safi Biosolutions make money?
One revenue line is on record: mRBC Biologic Product Sales.
Who are Safi Biosolutions's main competitors?
Direct peers on record are Rubius Therapeutics, KaloCyte and Cellphire Therapeutics. Hemarina is listed as an emerging player. Broad incumbents are Vertex Pharmaceuticals, bluebird bio, Octapharma, CSL Behring and American Red Cross. ARMI | BioFabUSA is listed as an others.
Does Safi Biosolutions have an API?
No public API is recorded for Safi Biosolutions.
What industry is Safi Biosolutions in?
Safi Biosolutions's product category is Cell Therapy Biologics. Its primary akta.pro industry code is HLAAABAE, Stem Cell Therapies (MSC/iPSC/HSC-derived), with a secondary code of HLAAAKAC, Cell Therapy Manufacturing Services (GMP, autologous/allogeneic). Its NAICS code is 325414 and its SIC code is 2836.