Blood shortages can have severe implications for patients, forcing medical professionals to make difficult choices regarding who requires transfusions most urgently. The American Red Cross is responsible for collecting and distributing approximately 40% of the blood supply in the United States and is actively encouraging more individuals to donate.
Last month, the American Red Cross announced a critical shortage of blood supplies, reporting a decrease of over 25% in its national inventory during July. In response to this crisis, one innovative startup is focusing on lab-grown blood as a potential solution.
Doug McConnell, the CEO of Safi Biotherapeutics, believes that hospitals and clinics should not have to depend solely on donations in the future. His four-year-old startup is dedicated to producing affordable red blood cells at a large scale.
While scientists have already made strides in cultivating red blood cells from stem cells, the existing methods are often expensive and intricate, resulting in limited production quantities. For example, in a clinical trial conducted in November 2022, researchers in the U.K. managed to transfuse only about one or two teaspoons of lab-created blood into participants.
Safi aims to leverage these scientific advancements to manufacture substantial volumes of blood that could eventually be available for commercial use, helping to alleviate blood shortages.
To date, Safi has secured over $16 million in funding from the U.S. Department of Defense, with expectations that this amount could surpass $20 million by year-end due to an additional grant in progress. Recently, the company also revealed a $5 million seed funding round led by J2 Ventures. McConnell stated that this combined financial support will be crucial as Safi begins its collaboration with regulators from the U.S. Food and Drug Administration (FDA).
Currently, the FDA has not approved Safi’s technology for use, and the company faces several years of stringent testing to validate the functionality and safety of its red blood cells. Additionally, Safi must demonstrate that its production methods comply with the FDA’s standards.
“We need to show these are safe, we need to show they’re effective, that they’re doing their job: They deliver oxygen, they circulate in a way that’s comparable to a donor red blood cell,” McConnell emphasised.
The production process at Safi begins with a “progenitor” cell, which is a versatile cell capable of developing into various cell types. These progenitor cells are sourced from stem cells found in bone marrow, which Safi then transforms into red blood cells.
McConnell likened the process of growing red blood cells to making a stew, as it requires a variety of components. The challenge lies in determining the most cost-effective and efficient recipe, including when to stir or agitate the mixture and which ingredients can be replaced with cheaper alternatives.
Safi is also customising its production recipes for specific patient demographics, as certain patients with chronic transfusion needs require blood that lacks specific antigens.
The cells multiply by dividing or “doubling” within a bioreactor. McConnell explained that Safi closely monitors the number of doublings achieved during bioreactor operations, as this metric indicates the efficiency of cell production. After filtration, Safi obtains units or bags of blood that visually resemble those collected from donors.
Currently, Safi estimates that it can produce one unit of blood for less than $2,000. The company aims to reduce this cost to under $500 or even $300 per unit, aligning with the price of donor blood, according to McConnell.
McConnell indicated that the company’s first product launch is likely six or seven years away, as it aims to produce around 100,000 units of blood in its inaugural year. The long-term plan is to scale up production to exceed one million units annually.
He also expressed his desire for doctors and patients to have peace of mind regarding blood availability, asserting that Safi can help bridge existing gaps in supply.
