Last month, the American Red Cross declared a Emergency anemia after nationwide supplies fell by greater than 25% in July. A startup's solution: lab-grown blood.
Shortages might be devastating 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, in accordance with its website, and the organization is beg more people donate.
But if Doug McConnell has his way, hospitals and clinics won't need to depend on donations endlessly. McConnell is CEO of a four-year-old startup called Safi Biotherapeutics, which is working to provide inexpensive red blood cells at scale.
Scientists have already discovered grow red blood cells from stem cells, nevertheless it is a costly and sophisticated process that typically produces only small amounts at a time. In November 2022, for instance, researchers within the UK successfully transfused As a part of a clinical study, about one to 2 teaspoons of artificial blood are administered to people.
Safi's goal is to construct on these advances and produce large quantities of blood that might at some point be used commercially to take care of patients and forestall 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 greater than $16 million from the U.S. Department of Defense thus far, and because of one other ongoing grant, that quantity could exceed $20 million by yr's end. The company also recently announced it has received a further $5 million in seed funding led by J2 Ventures. McConnell said this combined funding will help the corporate begin its work with regulators on the U.S. Food and Drug Administration.
The FDA has not yet approved Safi's technology to be used, and the corporate still has years of rigorous testing to prove its red blood cells are functional and secure. The company must also reveal 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.
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 a component of an ecosystem that receives government funding to expand biomanufacturing capability within the U.S.
Safi starts its production process with a “precursor cell,” an adaptable cell that may turn into differing kinds. Precursor cells come from stem cells within the bone marrow, and Safi converts them into red blood cells.
McConnell said growing red blood cells is a bit like making a stew since it requires many alternative ingredients. The challenge, nevertheless, is finding the most cost effective and best recipe, determining when to stir or shake the stew, and which ingredients might be replaced with cheaper alternatives.
The company also develops special formulations for certain patient groups, as some chronic blood transfusion patients require blood that is freed from certain antigens.
The cells grow by dividing, or “doubling,” as they’re passed through a bioreactor. McConnell said Safi spends a whole lot of time specializing in what number of doublings it achieves during bioreactor runs because that's a very good indication of how efficiently it's producing cells. The cells are filtered, and Safi receives units, or bags, of blood that look identical to what can be collected from a donor.
Safi believes it’s currently capable of produce a unit of blood for under $2,000. The company's ultimate goal is to cut back costs to under $500 and even $300 per unit, which is comparable to the value of donated blood, McConnell said.
The average amount U.S. hospitals paid for a unit of donated red blood cells was $214 in 2021, in accordance with 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 corporate hopes to make use of much larger tanks that may produce about 100 units per run. That means only one stem cell donation could help produce a whole lot of luggage of blood.
“That’s more than one person could donate in their lifetime,” McConnell said.
To achieve large-scale production, Safi still has a protracted strategy to go. McConnell said the corporate's launch will likely take one other six or seven years, partially because the corporate is aiming to provide around 100,000 units of blood in its first yr of launch. Safi plans to proceed to expand production until it produces greater than 1,000,000 units per yr, he added.
McConnell said he doesn't need to make doctors or patients worry about access to blood, and he believes Safi might 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.”
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