Mother holding a newborn in a hospital bed.
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In 2020, in a nondescript office constructing in Durham, North Carolina, a team of scientists used cells to recreate sugar and protein present in breast milk.
The seemingly area of interest development could years later change the way in which infant nutrition is known and distributed in America.
Biomilq, the corporate behind the breakthrough, had been working for nearly a decade to copy the technique of making human milk — but outside of the body. Its advancement was made possible by lots of of volunteers, who donated samples of their milk so the corporate could construct a big enough cell bank to launch its process for replicating milk at scale.
Just two years after Biomilq’s lightbulb moment, the invention’s potential advantages got here into focus when several major baby formula brands were recalled, sending your entire industry right into a tailspin, jacking up prices and putting latest parents in a desperate bind.
Greater than a 12 months after supply first ran low, a former Food and Drug Administration official said in late March that the American infant-formula supply remains to be vulnerable to disruptions and issues of safety.
The formula shortage has laid bare the frailty of the infant-nutrition supply, which only underscored the importance of Biomilq’s vision and its potential to fill a necessity, based on its co-founder and CEO Leila Strickland.
“The infant-formula shortage was an inevitability due to the way in which we produce it on this country,” Strickland said. “Once we are making all the food, to feed all the babies, and it’s such a small variety of plants … there’s going to eventually be an event like this.”
While the crisis has highlighted the importance of a resilient formula supply, human milk experts, milk bank advocates and Biomilq all stress the identical message: Breast milk is best. But many U.S. policies, including a scarcity of paid parental leave, make that an unfeasible option for a lot of parents.
If Biomilq can get its breakthrough science to market and keep prices down, it has “the potential to be a game-changer,” based on Maryanne Perrin, a professor who studies human milk on the University of North Carolina Greensboro.
There’s also an upside for the climate: Many infant formulas depend on powdered cow’s milk, production of which exacts a serious environmental toll. On the strength of its climate-friendly potential, Biomilq received $3.5 million in 2020 from Bill Gates’ Breakthrough Energy Ventures, an investment firm focused on climate solutions.
Once all of Biomilq’s technology is in place, Perrin thinks it could extend to other, greater markets, like producing cow’s milk in a cell-culture model.
“The technology has the potential to affect a ton of industries,” she said.
But before Biomilq can do any of that, it should have to seek out its place inside a historically contentious industry, navigate startup challenges and clear significant regulatory hurdles.
Where does Biomilq slot in?
It’s unclear what share Biomilq will absorb the worldwide infant-formula market, which is predicted to be valued at over $100 billion by 2032, particularly given debates over breastfeeding alternatives.
Biomilq doesn’t aim to interchange breastfeeding or infant formula, but supporters of each methods have opposed alternatives up to now. In an effort to carve out an area within the industry, Biomilq may have to make it clear that its products are supposed to fit into the prevailing ecosystem of infant nutrition, said Perrin and Lindsay Groff, executive director of the Human Milk Banking Association of America.
Strickland acknowledges that Biomilq falls “on this valley” between breastfeeding and formula — a reality that complicates its path to the market. She said she ultimately desires to support access to all infant-nutrition options.
Strickland said she has spoken with infant-formula firms that need to understand how Biomilq’s technologies could improve their existing formulas. The startup will likely take a “gradual approach” to introducing its science via “an early-life nutrition product in partnership with one in all these greater firms,” Strickland explained.
With time, she hopes to eventually create a product that has “an entire profile of macronutrients” like human milk, while meeting the “functional definition of milk from a composition standpoint.”
Still, don’t expect to see Biomilq next to Gerber products anytime soon. Even “simpler prototype iterations” of its product, like collaborations with infant-formula firms, will take somewhere between three and five years to come back to fruition, while an entire human milk product “might be even further out,” Strickland said.
She also hopes to make use of Biomilq’s platform to bring visibility to the institutional and physiological barriers to breastfeeding. Other breast milk experts need to see the identical thing.
“What could be great is that if there was investment in breastfeeding support, because if there was more breastfeeding, the necessity for formula, the necessity for donor milk, or every other options being brought up now could be lessened,” Groff said. “That is what all of us want: healthy babies.”
Unlike the infant-formula industry, which incorporates heavyweights like Gerber and Nestle, Perrin noted there’s “no company behind breast milk.” That is made enshrining protections for breastfeeding particularly difficult, despite the efforts of breastfeeding advocacy groups.
Amid this complicated landscape, Biomilq also may have to persuade consumers to get on board with a groundbreaking product in an industry that lacks research and public understanding. Breast milk is woefully understudied — to the purpose that it’s difficult “to even say what human milk is from a dietary standpoint,” Perrin explained.
It’s such an issue that Strickland said one in all her common “stumper interview questions” for brand new hires is solely: “What’s milk?”
Fittingly, Biomilq’s research may also fill existing gaps in our understanding of human milk. The corporate is researching which facets of human milk its system is best suited to supply.
“There are not any two samples of milk ever, anywhere on the planet which are the identical from a composition standpoint,” Strickland said. To create a full milk product, relatively than a formula hybrid, Biomilq may have to create a production process that could make its product “consistently and stably every batch,” she added.
A tricky time for startups
Along with entering a difficult and under-researched industry, Biomilq also has to grapple with growing pains common to startups. Strickland founded Biomilq alongside food scientist Michelle Egger, who left the corporate in March. Strickland, who was previously chief scientific officer, took over as CEO.
Strickland wouldn’t comment on any specifics regarding Egger’s departure, beyond citing “some shifts in excited about the direction of the corporate and the strategy overall.”
Egger told CNBC she has been advised to not comment further about Biomilq because she left the corporate.
Prior to the departure, Strickland’s partnership with Egger gave the look of a fortuitous one. Strickland, who accomplished a postdoctoral fellowship in cell biology at Stanford University, could handle the science, while Egger, who began her profession at General Mills and helped develop Lärabar and Go-Gurt, had solid experience introducing modern food products.
As CEO, Strickland will likely bring an excellent deeper emphasis on Biomilq’s science. She wants the corporate to make use of its research as “a community exercise,” by publishing, sharing and in search of peer review for its findings, in addition to engaging with the scientific community.
To make certain, Biomilq faces startup-specific challenges. The corporate emerged within the heyday of investor interest in lab-grown alternatives to common consumer products: In 2013, the first lab-grown burger was developed and publicly tasted by a scientist, sparking wider interest in cell-oriented products.
For a time, funding flowed: Along with the money received from Bill Gates’ investment firm, Biomilq also raised $21 million in its Series A rounds in 2021, Strickland said.
Now, the tide may be turning.
“At once, we’re on this weird swirl in biotech where there’s a variety of anxiety about enterprise capital-backed initiatives like Biomilq,” she said, adding that Biomilq is increasingly focused on ensuring it has “enough operating capital to endure what’s looking like a tougher funding environment within the immediate future.”
Biotech funding reached a record high of $77 billion in 2021, per Crunchbase data, however it then dipped 38.6% between 2021 and 2022. That decline will likely only be made worse by the collapse of Silicon Valley Bank, where a wide swath of U.S. biotech firms banked. Though the collapse only directly impacted a handful of biotech firms, small biotech firms may be hard-pressed to seek out one other lender.
“It has been a grow fast phase, and now the entire ecosystem is shifting to a survival phase,” Strickland added.
Convincing parents can be no small feat
For all of Biomilq’s challenges, Strickland said its path forward still looks “pretty similar” to other firms within the food tech space “developing foods from a very novel technology.” One in every of its biggest hurdles in bringing a product to market is government regulation, which can likely be much more stringent than the oversight other firms face, because Biomilq is within the business of feeding infants.
Though it remains to be years away from getting a product to market, Biomilq has began talks with the Food and Drug Administration, which can ultimately regulate the corporate, Strickland said.
“Mostly at this stage, it’s about being upfront and transparent about: ‘What will we envision this becoming?'” she said. “Inside the FDA specifically, they have been really affected by the formula shortage and recognize the necessity for innovation on this space.”
Groff added that even when Biomilq surmounts the “huge challenge” of FDA approval, the corporate will face an uphill battle convincing latest parents to feed their babies an unfamiliar product.
“It’s such a novel concept that it isn’t exactly clear how consumers are going to reply after they have this feature available that is produced in such an unusual way,” Strickland added.
But none of that makes Biomilq’s potential any less exciting to those like Groff and Perrin, who study infant nutrition. Strickland said she is prepared for any challenges ahead, since the payoff feels value it.
“It really could change the way in which we take into consideration feeding infants,” she said. “It’s really exciting to be an element of that conversation — even at this stage.”