Safi employees at work.
Courtesy of Safi Biotherapeutics
Last month, the American Red Cross declared a blood shortage after the nationwide supply dropped by more than 25% in July. One startup's solution: lab-grown blood.
Shortages can be severe for patients, as doctors must make difficult decisions about who needs blood transfusions most. The American Red Cross collects and distributes about 40% of the U.S. blood supply, according to its website, and is asking more people to donate.
But if Doug McConnell has his way, hospitals and clinics won't have to rely on donations forever. McConnell is CEO of a four-year-old startup called Safi Biotherapeutics, which is working to produce inexpensive red blood cells at scale.
Scientists have already figured out how to grow red blood cells from stem cells, but it's a costly and complex process that typically produces only small amounts at a time. In November 2022, for example, researchers in the UK successfully transfused about one to two teaspoons of artificial blood into people as part of a clinical trial.
Safi's goal is to build on these advances and produce large quantities of blood that could one day be used commercially to care for patients and prevent blood shortages.
“People have tried, but technology has moved on 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 doubt about that.”
Safi has received more than $16 million from the U.S. Department of Defense so far, and thanks to another ongoing grant, that amount could exceed $20 million by year's end. The company also recently announced it has received an additional $5 million in seed funding led by J2 Ventures. McConnell said this combined funding will help the company begin its work 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 has years of rigorous testing to prove its red blood cells are functional and safe. The company must also demonstrate that its manufacturing process meets the agency's standards.
“We need to show that they are safe, we need to show that they are effective, that they do their job: they deliver oxygen, they circulate in a way that is comparable to a donor's red blood cells,” McConnell said.
Safi's bioreactor plant.
Courtesy of Safi Biotherapeutics
Earlier this month, Safi began working with a Manchester, New Hampshire, manufacturer called the Advanced Regenerative Manufacturing Institute (ARMI) to optimize its production process. McConnell said ARMI is part of an ecosystem that receives government funding to expand biomanufacturing capacity in the U.S.
Safi starts its production process with a “precursor cell,” an adaptable cell that can develop into different types. Precursor cells come from stem cells in the bone marrow, and Safi converts them into red blood cells.
McConnell said growing red blood cells is a bit like making a stew because it requires many different ingredients. The challenge, however, is finding the cheapest and most effective recipe, figuring out when to stir or shake the stew, and which ingredients can be replaced with less expensive alternatives.
The company also develops special formulations for certain patient groups, as some chronic blood transfusion patients require blood that is free of certain antigens.
The cells grow by dividing, or “doubling,” as they are passed through a bioreactor. McConnell said Safi spends a lot of time focusing on how many doublings it achieves during bioreactor runs because that's a good indication of how efficiently it's producing cells. The cells are filtered, and Safi receives units, or bags, of blood that look just like what would be collected from a donor.
Safi made red blood cells.
Courtesy of Safi Biotherapeutics
Safi believes it is currently able to produce a unit of blood for under $2,000. The company's ultimate goal is to reduce costs to under $500 or even $300 per unit, which is comparable to the price of donated blood, McConnell said.
The average amount U.S. hospitals paid for a unit of donated red blood cells was $214 in 2021, according to a report by analytics firm Statista.
McConnell said Safi can currently use a 10-liter bioreactor that produces about one unit of blood per run. In eight or nine years, McConnell said, the company hopes to use much larger tanks that can produce about 100 units per run. That means just one stem cell donation could help produce hundreds of bags of blood.
“That’s more than one person could donate in their lifetime,” McConnell said.
To achieve large-scale production, Safi still has a long way to go. McConnell said the company's launch will likely take another six or seven years, in part because the company is aiming to produce around 100,000 units of blood in the first year of launch. Safi wants to continue to increase production until it is making more than a million units per year, he added.
McConnell said he doesn't want to make doctors or patients worry about access to blood, and he believes Safi can help fill those gaps.
“It's kind of crazy that we're still tolerating this,” he said. “Frankly, one of the solutions … is to build our own supply chain.”
Comments are closed.