Safi Biosolutions

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.

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

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

• Cell therapy biomanufacturing
• Cultured red blood cells
• Blood transfusion products
• Stem cell therapeutics
• Cryopreserved biologics

Headquarters

HQ city

Arlington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Infrastructure, Supply Chain

Revenue model

1. 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

Core 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

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered core and supporting.

• DesiCorp Inc.coreStrategic or Co-development Partner · 31 March 2026Collaboration 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 FluidicssupportingTechnology or Integration · 16 July 2025Collaboration 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)coreStrategic or Co-development Partner · 24 April 2025NIH 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 | BioFabUSAcoreStrategic or Co-development Partner · 10 February 2025Collaboration 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.
• EryPharmcoreStrategic or Co-development Partner · 5 January 2024Acquisition 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 ProgramcoreStrategic or Co-development Partner · 1 October 2019Safi 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

Direct 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

• LinkedInlinkedin.com/company/safi-biotherapeutics-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Safi Biosolutions