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In 2020, in a nondescript office building in Durham, North Carolina, a team of scientists used cells to recreate sugar and protein found in breast milk.
The seemingly niche development could years later change the way infant nutrition is understood and distributed in America.
Biomilq, the company behind the breakthrough, had been working for nearly a decade to replicate the process of making human milk — but outside of the body. Its advancement was made possible by hundreds of volunteers, who donated samples of their milk so the company could build a large enough cell bank to launch its process for replicating milk at scale.
Just two years after Biomilq's lightbulb moment, the invention's potential benefits came into focus when several major baby formula brands were recalled, sending the entire industry into a tailspin, jacking up prices and putting new parents in a desperate bind.
More than a year after supply first ran low, a former Food and Drug Administration official said in late March that the American infant-formula supply is still vulnerable to disruptions and safety issues.
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 need, according to its co-founder and CEO Leila Strickland.
"The infant-formula shortage was an inevitability because of the way we produce it in this country," Strickland said. "When we are making all of the food, to feed all of the babies, and it's such a small number 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 same message: Breast milk is best. But many U.S. policies, including a lack of paid parental leave, make that an unfeasible option for many parents.
If Biomilq can get its breakthrough science to market and keep prices down, it has "the potential to be a game-changer," according to Maryanne Perrin, a professor who studies human milk at the University of North Carolina Greensboro.
There's also an upside for the climate: Many infant formulas rely on powdered cow's milk, production of which exacts a major 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, bigger markets, like producing cow's milk in a cell-culture model.
"The technology has the potential to impact a ton of industries," she said.
But before Biomilq can do any of that, it will have to find its place within a historically contentious industry, navigate startup challenges and clear significant regulatory hurdles.
Where does Biomilq fit in?
It is unclear what share Biomilq will take in the global infant-formula market, which is expected to be valued at over $100 billion by 2032, particularly given debates over breastfeeding alternatives.
Biomilq does not aim to replace breastfeeding or infant formula, but supporters of both methods have opposed alternatives in the past. In order to carve out a space in the industry, Biomilq will have to make it clear that its products are meant to fit into the existing ecosystem of infant nutrition, said Perrin and Lindsay Groff, executive director of the Human Milk Banking Association of America.
Strickland acknowledges that Biomilq falls "in this valley" between breastfeeding and formula — a reality that complicates its path to the market. She said she ultimately wants to support access to all infant-nutrition options.
Strickland said she has spoken with infant-formula companies that want to know 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 of these bigger companies," Strickland explained.
With time, she hopes to eventually create a product that has "a complete 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 companies, will take somewhere between three and five years to come to fruition, while a complete human milk product "is probably even further out," Strickland said.
She also hopes to use Biomilq's platform to bring visibility to the institutional and physiological barriers to breastfeeding. Other breast milk experts want to see the same thing.
"What would be great is if there was investment in breastfeeding support, because if there was more breastfeeding, the need for formula, the need for donor milk, or any other options being brought up now would be lessened," Groff said. "That's what we all want: healthy babies."
Unlike the infant-formula industry, which includes heavyweights like Gerber and Nestle, Perrin noted there's "no company behind breast milk." That's made enshrining protections for breastfeeding particularly difficult, despite the efforts of breastfeeding advocacy groups.
Amid this complicated landscape, Biomilq also will have to convince 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 point that it's difficult "to even say what human milk is from a nutritional standpoint," Perrin explained.
It's such a problem that Strickland said one of her common "stumper interview questions" for new hires is simply: "What is milk?"
Fittingly, Biomilq's research will also fill existing gaps in our understanding of human milk. The company is researching which aspects of human milk its system is best suited to produce.
"There are no two samples of milk ever, anywhere on the planet that are the same from a composition standpoint," Strickland said.To create a full milk product, rather than a formula hybrid, Biomilq will have to create a production process that can make its product "consistently and stably every batch," she added.
A tough time for startups
In addition to entering a challenging 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 company in March. Strickland, who was previously chief scientific officer, took over as CEO.
Strickland would not comment on any specifics regarding Egger's departure, beyond citing "some shifts in thinking about the direction of the company and the strategy overall."
Egger told CNBC she has been advised not to comment further about Biomilq because she left the company.
Prior to the departure, Strickland's partnership with Egger seemed like a fortuitous one. Strickland, who completed a postdoctoral fellowship in cell biology at Stanford University, could handle the science, while Egger, who started her career at General Mills and helped develop Lärabar and Go-Gurt, had solid experience introducing innovative food products.
As CEO, Strickland will likely bring an even deeper emphasis on Biomilq's science. She wants the company to use its research as "a community exercise," by publishing, sharing and seeking peer review for its findings, as well as engaging with the scientific community.
To be sure, Biomilq faces startup-specific challenges. The company emerged in 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: In addition to the cash received from Bill Gates' investment firm, Biomilq also raised $21 million in its Series A rounds in 2021, Strickland said.
Now, the tide might be turning.
"Right now, we're in this weird swirl in biotech where there's a lot of anxiety about venture 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 more difficult funding environment in the immediate future."
Biotech funding reached a record high of $77 billion in 2021, per Crunchbase data, but 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 companies banked. Though the collapse only directly impacted a handful of biotech companies, small biotech firms might be hard-pressed to find another lender.
"It's been a grow fast phase, and now the whole ecosystem is shifting to a survival phase," Strickland added.
Convincing parents will be no small feat
For all of Biomilq's challenges, Strickland said its path forward still looks "pretty similar" to other companies in the food tech space "developing foods from a totally novel technology." One of its biggest hurdles in bringing a product to market is government regulation, which will likely be even more stringent than the oversight other companies face, because Biomilq is in the business of feeding infants.
Though it is still years away from getting a product to market, Biomilq has started talks with the Food and Drug Administration, which will ultimately regulate the company, Strickland said.
"Mostly at this stage, it's about being upfront and transparent about: 'What do we envision this becoming?'" she said. "Within the FDA in particular, they've been really affected by the formula shortage and recognize the need for innovation in this space."
Groff added that even if Biomilq surmounts the "huge challenge" of FDA approval, the company will face an uphill battle convincing new parents to feed their babies an unfamiliar product.
"It's such a novel concept that it's not exactly clear how consumers are going to respond when they have this option available that's 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 ready for any challenges ahead, because the payoff feels worth it.
"It really could change the way we think about feeding infants," she said. "It's really exciting to be a part of that conversation — even at this stage."
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