Safi employees at work.
Provided by Safi Biotherapeutics
Last month, the American Red Cross announced emergency blood shortage National supply fell by more than 25% in July. One startup’s solution: lab-grown blood.
Blood shortages can be scary for patients, as doctors must make difficult decisions about who needs transfusions the most. The American Red Cross collects and distributes about 40% of the U.S. blood supply, according to its website, and the organization is plead for more people Donate.
But if Doug McConnell gets 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 working to mass-produce cheap red blood cells.
Scientists have discovered how to grow red blood cells from stem cells, but it's a costly and complex process that usually produces only a small number of red blood cells at a time. For example, in November 2022, researchers in the United Kingdom Transfusion successful As part of the clinical trial, about one to two teaspoons of the artificial blood was injected into the body.
Safi's goal is to build on these advances and produce large quantities of blood that could eventually be used commercially to help care for patients and avoid blood shortages.
“People have tried, but the technology has evolved and we now see the path,” McConnell told CNBC. “I do think it went from science fiction to science, but there's still a lot of work to be done. . ”
To date, Safi has received more than $16 million from the U.S. Department of Defense, and thanks to additional ongoing appropriations, the total 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 the combined financing will help support the company as it begins working with regulators at the U.S. Food and Drug Administration.
The FDA has not yet approved Safi's technology for use, and the company still needs several years of rigorous testing to prove the functionality and safety of its red blood cells. The company must also demonstrate that its manufacturing processes meet the agency's standards.
“We need to show that they are safe, we need to show that they are effective, that they are doing their job: they are providing oxygen, they are circulating in a manner comparable to donor red blood cells,” McConnell said.
Safi's bioreactor setup.
Provided by Safi Biotherapeutics
Earlier this month, Safi began working with a manufacturer called the Advanced Regenerative Manufacturing Institute (ARMI) in Manchester, New Hampshire, to fine-tune its production process. McConnell said ARMI is part of an ecosystem that has been receiving government funding to build biomanufacturing capabilities in the United States
Safi begins its production process with a “progenitor” cell, meaning an adaptive cell that can grow into different types. The progenitor cells come from stem cells within the bone marrow, and Safi converts them into red blood cells.
Growing red blood cells is almost like preparing a stew, McConnell said, in that it requires many different ingredients — the challenge, though, is figuring out the cheapest, most effective recipes, as well as when to stir or stir the stew and which ingredients can Replaced by lower cost alternatives.
The company also designs special formulations for specific patient groups, as some long-term transfusion patients require blood that is free of certain antigens.
When cells enter a bioreactor, they grow by dividing or “doubling”. Safi spent a lot of time focusing on how many doublings were achieved during a bioreactor run, McConnell said, because that was a good indication of how efficiently it was producing cells. After the cells were filtered, Safi was left with units or bags of blood that looked identical to the blood collected from the donor.
Red blood cells made by Safi.
Provided by Safi Biotherapeutics
Safi estimates that it can currently produce a unit of blood for less than $2,000. McConnell said the company's ultimate goal is to bring the cost down to less than $500 or even $300 per unit, comparable to the price of donated blood.
According to a report by analytics firm Statista, the median amount U.S. hospitals paid per unit of donated red blood cells in 2021 was $214.
Safi is currently able to use a 10-liter bioreactor, which can produce about one unit of blood per run, McConnell said. He said the company hopes to use larger tanks within eight or nine years, producing about 100 units per operation. This means just one stem cell donation can help produce hundreds of bags of blood.
“That's more than one person can donate in a lifetime,” McConnell said.
Safi still has a long way to go before achieving mass production. McConnell said the company's initial rollout could take another six to seven years, in part because it aims to produce about 100,000 units of blood within a year of initial launch. He added that Safi plans to continue to expand until annual production exceeds 1 million units.
McConnell said he doesn't want doctors or patients to worry about getting blood, and he believes Safi can help fill those gaps.
“It's kind of crazy that we still tolerate this,” he said. “Honestly, one of the solutions is … to build our own supply chain.”