Safi employees at work.
Courtesy of Safi Biotherapeutics
Last month, the American Red Cross declared a blood emergency after the national supply dropped more than 25% in July. A beginner’s solution: Lab-grown blood.
The shortage can be dire for patients, as doctors must make tough decisions about who needs transfusions the most. The American Red Cross collects and distributes about 40% of the United States’ blood supply, and the organization is urging more people to donate.
But if Doug McConnell has his way, hospitals and clinics won’t have to rely on donations forever. McConnell is the CEO of Safi Biotherapeutics, a four-year-old startup that is trying to mass-produce cheap red blood cells.
Scientists have already discovered how to grow red blood cells from stem cells, but it’s an expensive and complicated process that usually only yields small quantities at a time. For example, in November 2022, researchers in England successfully transfused about one or two teaspoons of manufactured blood into humans as part of a clinical trial.
Safin’s goal is to build on these advances and eventually produce large quantities of blood that can be used commercially to care for patients and avoid blood shortages.
“People have tried, but the technology has advanced and we’re seeing that path now,” McConnell said in an interview with CNBC. “I think it’s moving from science fiction to science, but there’s still a lot of work to do. There’s no question about it.”
Safi has received more than $16 million from the US Department of Defense to date, and with an additional grant in process, that amount could exceed $20 million by the end of the year. The company also recently announced an additional $5 million in seed funding led by J2 Ventures. McConnell said this combined funding will support the company as it begins to work with U.S. Food and Drug Administration regulators.
The FDA has not approved Safi’s technology for use, and it will take years of rigorous testing to prove that the company’s red blood cells are both functional and safe. The company will also have to demonstrate that its manufacturing process meets the agency’s standards.
“We have to show that they’re safe, we have to show that they’re effective, that they do their job: They deliver oxygen, they circulate in a way comparable to a donor red blood cell,” McConnell said.
Safin’s bioreactor unit.
Courtesy of Safi Biotherapeutics
Earlier this month, Safi began working with a manufacturer called the Advanced Regenerative Manufacturing Institute (ARMI) in Manchester, New Hampshire, to streamline the manufacturing process. McConnell said ARMI is part of an ecosystem that receives government funding to develop biomanufacturing capabilities in the United States.
Safi starts the production process with an “ancestor” cell, that is, an adaptable cell that can transform into different types. The progenitor cells come from stem cells in the bone marrow, and Safi turns them into red blood cells.
Growing red blood cells is almost like making a stew, McConnell said, because it requires so many different ingredients — although the challenge is finding the cheapest and most effective recipe possible, as well as when to stir or stir the stew. can be replaced by cheaper alternatives.
The company also develops special formulations for specific patient populations, as some chronically transfused patients require blood purified from certain antigens.
When the cells are passed through the bioreactor, they divide or “double” in size. McConnell said Safi spends a lot of time focusing on how much doubling the bioreactor achieves during its run, because that’s a good indicator of how efficient cell production is. The cells are filtered out and Safi is left with blood units or bags that resemble blood that would be collected from a donor.
Red blood cells produced by Safin.
Courtesy of Safi Biotherapeutics
Safi projects that it can now produce a unit of blood for less than $2,000. McConnell said the company’s ultimate goal is to bring costs down to $500 or even $300 per unit, comparable to the cost of donated blood.
According to a report by Statista, the average amount paid by US hospitals for one unit of red blood cells in 2021 was $214.
Safi is currently able to use a 10-liter bioreactor that produces about one unit of blood per run, McConnell said. In eight or nine years, the company said it hopes to use larger tanks that can produce about 100 units per run. This means that just one stem cell donation can help produce hundreds of bags of blood.
“It’s something that more than one person can donate during their lifetime,” McConnell said.
Safi has a long way to go before making large-scale production a reality. McConnell said the company’s first release is likely six or seven years away, in part because it aims to produce about 100,000 units of blood in its first year of release. Safi plans to scale up until it produces more than 1 million units annually, he added.
McConnell said he doesn’t want doctors or patients to worry about getting blood, and believes Safin can help fill those gaps.
“It’s kind of crazy that we’re still putting up with this,” he said. “Honestly, one of the solutions … is to build our own supply chain.”
