UNMET NEEDS

1. Problem Statement

Globally, hundreds of millions of people experience hemorrhages in the form of traumatic injury, obstetric bleeding, and pediatric anemias, requiring immediate access to blood transfusion. Blood loss causes the majority of deaths outside of a hospital, claiming 1.5 million lives each year in the United States [1]. Rapid access to blood transfusions is critical to preventing mortality, but treatment is often constrained by blood type compatibility, which is exacerbated in emergencies, remote locations, and in communities with poor blood banking infrastructure [2], [3], [4]. Ideally, every clinic would carry a supply of O type blood, which can be safely transfused to any ABO group [5]. Enzymatic conversion—using glycosidic enzymes to remove A or B antigens from red blood cells—can generate universal red blood cells (ECO RBCs), increasing the supply of O blood [6], [7]. However, key limitations of previous approaches were that they were unable to target ‘extended’ antigen variants, and they did not account for mismatched leukocytes, increasing the risk of graft vs host disease (GVHD).

Access to type-matched blood is a global problem, but blood shortages are most fatal in low-resource or urgent settings [8]. These environments lack high volume centrifuges necessary for removing immunoactive components and even long term cold storage [9]. Portable solutions like gravity sedimentation require custom microfluidics [10], while small-pore filters cost over $100 each and offer limited scale [11], [12]. Finally, standard blood typing devices are designed to qualitatively classify A, B, AB, or O but are not meant to assay antigen removal, nor are they quantitative [13]. The device also needs to be portable and operable with limited electricity for field use.

Addressing the lack of type matched blood with ECO RBCs, requires a comprehensive approach. An improved set of enzymes [14], thorough leukodepletion, and quantifiable blood typing. While a complete system would be needed for low resource settings, these technologies would increase the overall safety and accessibility of blood worldwide.

2. Beachhead Market

Blood transfusions represent a $25B market in the US [15]. However, ECO RBCs would be best established where they are needed most. Initially, our focus will be on funded development of our technology for emergency and disaster responders, military and defense medicine, space, or extreme environment missions. Similarly, we will seek funding to supply rural hospitals, small clinics, and Doctors Without Borders relief projects across the global south, which often lack blood banking capacity or have small donor pools. Once past clinical trials, we will move to commercialization while seeking support for extended testing in small emergency health clinics and rural communities in southern Arizona, such as the Tohono O’odham Nation and the San Carlos Apache Reservation, where the higher costs of blood distribution create a health disparity. Once our product is optimized, we will expand our services to low-resource communities outside of Arizona, and then rapidly scale for broad distribution. Ultimately, we see our product as an emergency kit, kept in reserve by hospitals, blood banks, and trauma centers everywhere.

Competitors

Our main competitors offer individual solutions for safer, more accessible blood transfusions, including enzymes for blood conversion, artificial red blood cells, “walking” blood banks, leukoreduction filters, and blood typing cards [16], [12], [17], [18], [19], [20]. In contrast, we propose an integrated enzymatic conversion kit combining lyophilized enzyme packs, a quantitative blood typing biosensor, and a biological leukoreduction filter. This approach is driven by several factors:

• Accessibility: Our kit uses lyophilized enzymes to reduce cold chain dependency and shipping costs, making enzymatic conversion more feasible in the field, with extended shelf life for general distribution. Additionally, our biological leukoreduction filter lowers costs compared to traditional filters.
• Safety: Our kit promotes safety through extended antigen targeting, rapid monitoring to check enzyme cleavage success, and leukoreduction.
• Portability: Our kit promotes ease of transport because the enzymes are lyophilized and the miniaturized design of the sensor.
• Monitoring: Our kit includes a quantitative biosensor for rapid monitoring, enabling us to quickly determine the antigen concentration of red blood cells and make a determination whether we have ECO RBCs or further purification is necessary.
• Reusability: The sensor’s robust design allows it to be reused for multiple tests with electrode cleaning steps in between.
• Increased Sustainability: The SCOBY-based leukoreduction filter enhances sustainability through biodegradability compared to traditional filters. Further design optimization is needed to minimize the remaining plastic components.

1. Benchmarking (TAM-SAM-SOM)

Enzymatic conversion of A and B red blood cells to O could become essential in blood banks, hospitals, military, and emergency medicine. Our primary goal is to ensure this process is safe and effective, and two significant markets we will be entering include the leukoreduction filter market and the blood diagnostics market.

• TAM (Total Addressable Market): The global market for blood products spans blood banks, hospitals, military and emergency medicine, and underserved communities. Within this, leukoreduction filters currently generate about $378.2 million, projected to reach $603.5 million by 2031 at an 8.1% CAGR [21]. Blood diagnostics is a larger market, valued at $4.7 billion and expected to grow to $6.96 billion at a 5.8% CAGR [22]. Both sectors are poised for significant growth, highlighting strong opportunities for innovation.
• SAM (Serviceable Available Market): Our realistic target market is North America, which holds 46.1% of the blood filtration market and is growing rapidly due to rising healthcare spending, medical technology advances, and an aging population [23]. It also dominates blood diagnostics with a 39.6% share, driven by the same factors [22], making the region a strategic focus for growth.
• SOM (Serviceable Obtainable Market): Our initial target market is Arizona, where the startup will launch and have access to local stakeholders. Arizona accounts for roughly 1.36% of the U.S. bioscience market [24]. translating to an estimated leukoreduction filter market of ~$2 million in 2025, growing to ~$3.4 million by 2031. The blood diagnostics market in Arizona is projected at ~$25.3 million in 2025, rising to ~$37.1 million by 2031, based on global growth rates of 8.1% and 5.8%, respectively.

Figure 12.Graph of TAM-SAM-SOM for the leukoreduction filter market (left).Graph of the TAM-SAM-SOM for the blood diagnostics market (right).

2. Customer Interview

As detailed on our Human Practices page, we spoke with experienced physicians in blood transfusions and banking to discuss our technology’s efficacy and its potential adoption in hospitals. These insights helped us identify key areas for improvement to optimize processes and ensure safe transfusion and testing of ECO RBCs. The main issues we identified pertain to ensuring successful enzymatic conversion. Current strategies for monitoring real-time enzymatic activity include highly specialized equipment that is both expensive and fixed to a laboratory, such as in spectrophotometry, fluorescence-based assays, mass spectrometry, or surface plasmon resonance [25], [26], [27], [28]. The need for on-site sensors for real-time analysis was emphasized during our meeting, as this would enable immediate feedback to re-treat the red blood cells with enzymes. Based on this feedback, we decided to pursue a portable strategy for the detection of antigen levels, eliminating the need for laboratory processing and allowing for rapid, cost-effective blood antigen analysis in just a few minutes. Furthermore, our interviews identified the limited options available on the market for portable filtration. Centrifugation is the typical strategy used in hospitals and blood banks, but it may not be available in underresourced or remote areas. To address these challenges, we researched portable, quantitative biosensors for enzymatic activity and antigen detection while exploring filtration strategies.

We also spoke with Dr. Karen Butterfield, a product development manager for WL Gore, a prevalent medical devices company in Arizona. She advised us to deeply consider the regulatory pathway for our product, arguing an enzymatic additive would be classified as a drug/biologic. She also advised us that sterilization could be an issue in the field, and so a closed system where the enzymes can be introduced directly into a blood bag without any external interaction with blood is ideal. Furthermore, she said we should expand our consideration of costs past the materials required to make each product, but also labor and transportation costs, and to consider how our kit reduces costs for each group of stakeholders- patients, physicians, providers, or pairs. Finally, she advised us to consider our initial market expansion to be outside of the US due to faster regulatory pathways. We utilized her advice into our hardware design, pricing strategy, and regulatory risk analysis.

Our Solution

UNIglobin Technology

UNIglobin proposes an innovative enzymatic blood conversion process aimed at helping underserved communities and emergency first responders to convert A, B, or AB type blood to type O. Furthermore, we propose a novel leukocyte reduction strategy using decellularized SCOBY and PTFE membrane filters to provide low-resource communities a cheaper alternative to leukoreduction filters or a centrifuge. Finally, it is incredibly important to ensure that the ECO RBCs are sufficiently cleaved before transfusion, so we propose a strategy to check the presence of antigens in the field, using lectins, which bind to antigens on red blood cells, and a redox enzyme, nitric oxide synthase, which allows us to quantitatively detect antigen presence with the help of a specialized sensor, the Miniaturized Electronic Antigen Biosensor (MEAB).

The product enables on-site conversion of red blood cells to type O using lyophilized, blood type–specific enzymes rehydrated in buffer. After enzymatic activity, plasma, leukocytes, residual enzymes, and free sugars are removed via the SCOBY filter: leukocytes bind to the SCOBY, while plasma and enzymes pass through the PTFE membrane and are washed out under positive pressure. ECO RBCs are then collected through the same flow path. Cleavage success is verified downstream using our electronic biosensor, where a lectin-redox complex binds remaining antigens and an electrode measures the redox reaction rate. Peak current correlates with antigen presence, ensuring safety before transfusion; if levels exceed the threshold, the blood is re-treated with enzymes.

Each component can also function independently. Lyophilized enzyme packs can supplement O blood supplies in hospitals or blood banks, reducing waste. SCOBY filters offer a low-cost alternative to traditional leukoreduction filters. The electronic biosensor provides quantitative blood typing and can be adapted for research by modifying the binding protein or redox enzyme.

Development Plans

1. IP Protection Strategy

Our project encompasses several innovative technologies. This includes lyophilized enzyme packs for the targeted cleavage of A, B, and extended antigens to type O red blood cells, an inexpensive plasma separation and leukoreduction filter, and a quantitative electronic blood typing sensor. Each of these technologies is patentable as is the overall process of using them in concert. After iGEM, we plan to further refine these technologies and secure patent protection for industrial implementation and scale.

2. Business Exit Strategy

UNIglobin’s strength lies in its overarching goal to provide underresourced communities with greater access to O blood and to facilitate the safe and effective transfusion of enzymatically converted red blood cells. Given the scope of the project, an exit strategy is crucial, especially for keeping goals focused, mapping the steps to achieve them, and demonstrating a clear path to returns that attracts investors.

The first exit strategy is acquisition by a large MedTech or diagnostics company such as QuidelOrtho, Terumo, or Baxter. These companies often seek innovation to extend their portfolios, and our enzymatic field conversion kit could be a strong acquisition target. They already have global sales channels, which makes it so we wouldn’t have to build a fresh distribution infrastructure. Furthermore, large companies often have established FDA/EMA/WHO regulatory departments. Our kit could go to market faster under their umbrella, which avoids regulatory bottlenecks that new startups often face [29]. Acquisition has the fastest liquidity and the highest scale potential.

The second option is licensing to blood banks, kit manufacturers, or military suppliers. With secured patents, we could earn royalties without building manufacturing or distribution infrastructure. Licenses could be modular—enzyme packs to diagnostics firms, filters to transfusion companies, sensors to point-of-care developers—allowing flexibility and retained ownership [30]. We recognize that optimizing the kit further for existing infrastructure would attract licensors.

The third option we’ve identified is a government / NGO buyout or long-term supply contract. The military (U.S. DoD, NATO, DARPA) and NGOs (WHO, Red Cross, Doctors Without Borders) value reliability and mission-critical innovation. Governments often subsidize or fund pilot deployments, which will lower the costs of R&D and lower the risk of commercialization [31].

3. Gantt Chart

4. Risk Analysis

The phases outlined in the Gantt chart are ideal but may face delays due to the inherent risks and uncertainties typical of startup development.

The main risks arise during research and development, including challenges with functionality, optimization, and cost [32]. A thorough risk analysis with contingency plans will enable quick pivots and demonstrate to investors our foresight, adaptability, and the project’s long-term potential. One key risk of the lyophilized enzyme packs is that enzyme activity observed at bench scale may not translate effectively to industrial use [33], requiring optimization of enzyme concentrations for processing fixed volumes of red blood cells. This product also carries the highest regulatory risk due to its direct role in transfusion workflows and potential classification as a drug, making clinical testing the most time-consuming compared to the filter or sensor. As it is designed to supplement rather than replace traditional blood banking, its initial market is expected to be limited.

A similar challenge exists with the leukoreduction filter. Although the filter components effectively bind leukocytes, the current process involves multiple steps and may require specialized training. The filter also carries high regulatory risk as a Class III medical device, necessitating extensive testing and validation. However, its market risk is relatively low since it competes mainly with more expensive existing filters.

Production scale-up presents additional considerations. Enzyme pack manufacturing can leverage established GMP bioreactor fermentation processes, while filter production requires precise culture, decellularization, and integration of SCOBY, likely demanding specialized equipment.

The final major risk involves optimizing the MEAB sensor, which is critical as the last checkpoint before transfusion and therefore requires rigorous development and testing. The current design—placing blood directly on the electrode—is suboptimal, as the sensor should minimize user interaction and biohazard exposure. While the MEAB has the lowest regulatory risk, it carries moderate market risk due to competition with cheaper blood typing tests, though its quantitative output and essential role in enzymatic conversion provide clear advantages.

5. Business Plan

Long Term Impacts

1. SWOT Analysis

2. PESTEL Analysis

3. Costs

Pricing Strategy

RBC concentration = 5,000,000 RBC / μL
Bag volume = 450 mL
Antigen sites per RBC (high scenario) = 2,000,000 sites / RBC
Unit definition based off NEB = 1 unit cleaves 1 nmol of substrate in 1 hour
Total RBCs in a blood bag = RBC concentration × bag volume = 2.25 × 10¹² RBC
Total antigens = RBCs × antigens per RBC = 4.5 × 10¹⁸ molecules
Moles of substrate = total antigens / 6.022 × 10²³ = 7.472 × 10^-6 mol
NEB units = moles of substrate / 1 nmol = 7472.6 NEB units are required to cleave all antigen sites in 1 hour in a bag assuming the maximum amount of antigen present.

Based on prices on enzymes per unit from medium scale producers like NEB and Promega:
α-N-acetylgalactosaminidase: $166 / 20,000 units = $0.0083 / unit
α-D-fucosidase: $159 / 20,000 units = $0.00795 / unit
β-D-galactosidase: $159 / 10,000 units = $0.0159 / unit
β-N-acetylgalactosaminidase: $83 / 10,000 units = $0.0083 / unit
α-D-galactosidase: $198.75 / 10,000 units = $0.019875 / unit

Per enzyme reagent cost
a-N-acetylgalactosaminidase cost: NEB units * price per unit of blood = $62.02
a-D-fucosidase cost: NEB units * price per unit of blood = $59.34
b-D-galactosidase cost: NEB units * price per unit of blood = $118.81
b-N-acetylgalactosaminidase cost: NEB units * price per unit of blood = $62.02
a-D-galactosidase cost: NEB units * price per unit of blood = $148.52

Pack level aggregation
Extended A pack contains a-N-acetylgalactosaminidase, a-D-fucosidase, and b-D-galactosidase Extended B pack contains b-N-acetylgalactosaminidase and a-D-galactosidase Each enzyme in the pack is dosed at the full units required.

A pack: $62.02*2 + $59.34 + 118.81 = $302.26
B pack: $62.02 + $148.52 = $210.54
AB pack: $302.26 + $210.54 = $512.80 per blood bag

4. Long-Term Development and Immediate Actions

Our project envisions long-term development opportunities for making tools to increase the supply, accessibility, and safety of transfusing enzymatically converted O blood. In the short term, our focus is ensuring our enzymes completely cleave the A, B, and extended antigen groups. Furthermore, we have determined that lyophilization does not significantly hinder enzymatic activity. Additionally, we need to consider the concentration of each lyophilized enzyme required per unit of blood that is optimal for full cleavage. Our first step is to optimize this concentration and test it in human blood.

Adding SCOBY into a PTFE membrane for plasma separation and leukoreduction can be a two-in-one approach to minimizing allogeneic reactions during transfusions. We hope to replace non-biodegradable PTFE with SCOBY in subsequent designs, as we are establishing SCOBY’s ability to pass proteins.

While our goal for field enzymatic conversion is to achieve complete cleavage, filtration, and detection, optimization will likely progress in stages. The filter and sensor will be optimized after cycles of development to achieve complete, safe, and accessible enzymatic conversion of any red blood cell to type O.

5. Marketing Strategy

In our early phase, it is paramount to build scientific credibility in order to attract partners and investors, as well as to prepare regulatory trust. Therefore, we plan to publish results of our findings in peer-reviewed journals, and to present prototypes at additional transfusion medicine, synthetic biology, and medtech conferences like the 2025 iGEM Jamboree, the American Association of Blood Banks (AABB) Annual Meeting, and the International Society of Blood Transfusion (ISBT) International Congress.

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