Safi employees at work.
With Safi Biotherapeutics
Last month, the American Red Cross declared an emergency blood shortage after the national supply dropped more than 25% in July. One initial solution: laboratory-grown blood.
Shortages can affect patients as doctors have to make difficult decisions about who needs a blood transfusion 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 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 the CEO of a four-year-old startup called Safi Biotherapeutics, which is working to produce cheap red blood cells at scale.
Scientists have found a way to grow red blood cells from stem cells, but the process is expensive and complicated and usually produces a small number. In November 2022, for example, researchers in England successfully transfused about one or two teaspoons of produced 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 can eventually be used commercially to care for patients and prevent blood shortages.
“People have tried, but the technology has evolved and we’re looking at this path now,” McConnell told CNBC in an interview. “I think it’s going from science fiction to science, but there’s still a lot of work to be done. There’s no question about that.”
Safi has received more than $16 million so far from the US Department of Defense, and that number could exceed $20 million by the end of the year due to additional funding in the process. The company also recently announced an additional $5 million in seed funding led by J2 Ventures. McConnell said this joint funding will help support the company as it begins to work with regulators from the US Food and Drug Administration.
The FDA has not yet cleared Safi’s technology for use, and the company has undergone years of rigorous testing to prove its red blood cells are functional and safe. Companies must also demonstrate that their manufacturing processes meet the agency’s standards.
“We have to show that it’s safe, we have to show that it’s effective, that it does its job: it delivers oxygen, it circulates in a way that’s comparable to donor red blood cells,” McConnell said.
Safi bioreactor rig.
With Safi Biotherapeutics
Earlier this month, Safi began working with a manufacturer in Manchester, New Hampshire, called the Advanced Regenerative Manufacturing Institute (ARMI) to perfect the production process. McConnell said ARMI is part of an ecosystem that has received government funding to build biomanufacturing capabilities in the US.
Safi starts the production process with “progenitor” cells, meaning adaptable cells that can grow into different types. Progenitor cells come from stem cells in the bone marrow, and Safi turns them into red blood cells.
McConnell says that growing red blood cells is almost like preparing a stew because it requires a variety of ingredients — the challenge, however, is figuring out the cheapest and most efficient recipe, as well as when stirring or stirring the stew and the ingredients that work. replaced by cheaper alternatives.
The company also designs special recipes for specific patient populations, as some chronically transfused patients require blood that is free of certain antigens.
Cells grow by dividing or “doubling” when put through a bioreactor. McConnell says Safi spends a lot of time focusing on how many doublings are achieved during the bioreactor’s run because that’s a good indication of how efficiently the cells are growing. The cells were filtered, and Safi was left with a unit, or bag, of blood that looked similar to what would be collected from a donor.
Safi produced red blood cells.
Available from Safi Biotherapeutics
Safi’s project can now produce one unit of blood for less than $2,000. The company’s main goal is to reduce costs to $500 or even $300 per unit, which is comparable to the price of donor blood, McConnell said.
The average amount that US hospitals pay for a unit of red blood cells donated will be $214 in 2021, according to a report from analytics company Statista.
McConnell said Safi is now able to use a 10-liter bioreactor that produces about one unit of blood per run. In eight or nine years, he said the company hopes to use a larger tank that will be able to generate around 100 units per run. This means that just one stem cell donation can help produce hundreds of blood bags.
“That’s more than one person can contribute in their lifetime,” McConnell said.
To make large-scale production a reality, Safi has a long way to go. McConnell said the company’s first launch will be six or seven years away, in part because it aims to produce about 100,000 units of blood during the initial launch year. Safi plans to continue scaling until it makes more than 1 million units a year, he said.
McConnell said he doesn’t want doctors or patients to worry about blood access, and he believes Safi can help fill that gap.
“It’s crazy that we’re still tolerating this,” he said. “Honestly, one of the solutions is to … build our own supply chain.”
