This government-backed startup is rising blood to assist combat shortages

Final month, the American Crimson Cross declared an emergency blood scarcity after its nationwide provide fell by greater than 25% in July. One startup’s resolution: Lab-grown blood.

Shortages will be dire for sufferers since docs need to make robust choices about who wants blood transfusions probably the most. The American Crimson Cross collects and distributes about 40% of the U.S.’ blood provide, per its web site, and the group is imploring extra individuals to donate. 

But when Doug McConnell has his method, hospitals and clinics will not need to depend on donations perpetually. McConnell is CEO of a four-year-old startup known as Safi Biotherapeutics, which is working to fabricate cheap pink blood cells at scale. 

Scientists have already found the way to develop pink blood cells from stem cells, nevertheless it’s a pricey and complicated course of that sometimes yields small quantities at a time. In November 2022, as an illustration, researchers within the U.Ok. efficiently transfused about one or two teaspoons of manufactured blood into individuals as a part of a medical trial. 

Safi’s aim is to construct on these developments and produce giant portions of blood that would ultimately be used commercially to assist take care of sufferers and keep away from blood shortages. 

“Individuals have tried, however the expertise has developed and we see this path now,” McConnell advised CNBC in an interview. “I do suppose it goes from science fiction to science, however nonetheless quite a lot of work forward. No query about that.” 

Safi has acquired greater than $16 million to this point from the U.S. Division of Protection, and that whole might exceed $20 million by the tip of the yr because of a further in-process grant. The corporate additionally just lately introduced a further $5 million in seed funding led by J2 Ventures. McConnell mentioned this mixed financing will assist help the corporate because it begins to work with regulators from the U.S. Meals and Drug Administration.

The FDA has not cleared Safi’s expertise to be used, and the corporate has years of rigorous testing forward with a view to show its pink blood cells to be each useful and protected. The corporate can even need to show that its manufacturing course of is as much as par with the company’s requirements. 

“We have to present these are protected, we have to present they’re efficient, that they are doing their job: They ship oxygen, they flow into in a method that is corresponding to a donor pink blood cell,” McConnell mentioned. 

Earlier this month, Safi started working with a producer in Manchester, New Hampshire, known as the Superior Regenerative Manufacturing Institute (ARMI) to fine-tune its manufacturing course of. McConnell mentioned ARMI is a part of an ecosystem that is been receiving authorities funding to construct out biomanufacturing capabilities within the U.S. 

Safi kicks off its manufacturing course of with a “progenitor” cell, which means an adaptable cell that may develop into differing types. Progenitor cells come from stem cells inside bone marrow, and Safi turns them into pink blood cells.

McConnell mentioned rising pink blood cells is nearly like getting ready a stew as a result of it requires plenty of totally different components — the problem, although, is determining the most cost effective and most effective recipe doable, in addition to when to stir or agitate the stew and which components will be substituted for less-costly alternate options.

The corporate can also be engineering particular recipes for particular affected person populations, as some persistent transfusion sufferers want blood that’s free from sure antigens. 

The cells develop by dividing or “doubling” when they’re put by a bioreactor. McConnell mentioned Safi spends quite a lot of time specializing in what number of doublings it achieves throughout bioreactor runs as a result of it is a good indication of how effectively it is producing cells. The cells are filtered, and Safi is left with models, or baggage, of blood that look the identical as what can be collected from a donor. 

Safi initiatives it’s at the moment in a position to produce one unit of blood for underneath $2,000. The corporate’s final aim is to get prices right down to underneath $500 and even $300 per unit, which is corresponding to the value of donor blood, McConnell mentioned. 

The median quantity that U.S. hospitals paid for a unit of donated pink blood cells was $214 in 2021, in keeping with a report from the analytics agency Statista.

McConnell mentioned Safi is at the moment in a position to make use of a 10-liter bioreactor that produces about one unit of blood per run. In eight or 9 years, he mentioned the corporate is hoping to make use of a lot bigger tanks that may be capable of generate round 100 models per run. This implies only one stem cell donation might assist produce tons of of luggage of blood.  

“It is multiple individual might donate of their lifetime,” McConnell mentioned.

To make large-scale manufacturing a actuality, Safi has an extended highway forward. McConnell mentioned the corporate’s first launch is probably going six or seven years away, partly as a result of it’s focusing on manufacturing of round 100,000 models of blood throughout its preliminary launch yr. Safi plans to proceed to scale till it is manufacturing greater than 1 million models yearly, he added. 

McConnell mentioned he would not need docs or sufferers to fret about entry to blood, and he believes Safi might help fill these gaps. 

“It is sort of loopy that we’re nonetheless tolerating this,” he mentioned. “Truthfully, one of many options is… to construct our personal provide chain.”