Mother holds a newborn baby in a hospital bed.
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In 2020, in a nondescript office building in Durham, North Carolina, a team of scientists used cells to mimic sugars and proteins found in breast milk.
Years later, the apparent niche development could change the way infant formula is understood and distributed in America.
Biomilq, the company behind the breakthrough, worked for almost a decade to replicate the process of making breast milk – albeit outside the body. The 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 scale up its milk replication process.
Just two years after Biomilq’s light bulb moment, the potential benefits of the invention became clear when several major baby formula brands were recalled, sending the entire industry into a tailspin, sending prices skyrocketing and leaving new parents in a desperate position.
More than a year after supplies first ran out, a former Food and Drug Administration official said in late March that America’s infant formula supply was still vulnerable to disruption and safety issues.
The shortage of infant formula has exposed the weakness of infant nutrition services, which only underscores the importance of Biomilq’s vision and its potential to fill a need. said co-founder and CEO Leila Strickland.
“The shortage of infant formula was inevitable because of the way we produce it in this country,” Strickland said. “If we make all the food to feed all the babies and there are so few plants… there will eventually be an event like this.”
While the crisis has highlighted the importance of a stable milk nutritional supply, breastmilk experts, milk bank advocates and Biomilq are all emphasizing the same message: breastmilk is best. But many U.S. policies, including the lack of paid parental leave, make this an unviable option for many parents.
If Biomilq can bring its breakthrough science to market and keep prices low, it has “the potential to be game-changers,” according to Maryanne Perrin, a professor studying human milk at the University of North Carolina Greensboro. .
There is also a positive side for the climate: Many infant formulas are based on cow’s milk powder, the production of which causes a high environmental impact. Due to its climate-friendly potential, Biomilq received $3.5 million in 2020 from Bill Gates’ Breakthrough Energy Ventures, an investment firm specializing in climate solutions.
Once all of Biomilq’s technology is in place, Perrin believes it could be expanded to other, larger markets, such as producing cow’s milk in a cell culture model.
“The technology has the potential to impact a lot of industries,” she said.
But before Biomilq can deliver any of this, it must find its place in a historically contentious industry, overcome startup challenges, and overcome significant regulatory hurdles.
Where does Biomilq fit in?
It’s unclear Biomilq’s share of the global infant formula market, which is expected to be worth over $100 billion by 2032, especially given the debates surrounding breastfeeding alternatives.
Biomilq does not aim to replace breastfeeding or infant formula, but proponents of both methods have historically opposed alternatives. To gain a place in the industry, Biomilq must make it clear that its products need to fit into the existing infant nutrition ecosystem, said Perrin and Lindsay Groff, executive directors of the Human Milk Banking Association of America.
Strickland acknowledges that Biomilq falls “in that valley” between breastfeeding and infant formula — a reality that has complicated its path to market. She said she ultimately wants to support access to all infant feeding options.
Strickland said she spoke to infant formula manufacturers who wanted to know how Biomilq’s technologies could improve their existing infant formulas. The startup will likely take a “phased approach” to rolling out its science through “an infant nutrition product in collaboration with one of these larger companies,” Strickland said.
Over time, she hopes to eventually develop a product that has “a complete macronutrient profile” like human milk, while still meeting the “functional definition of milk from a compositional standpoint.”
However, don’t expect Biomilq to be alongside Gerber products any time soon. Even “simpler prototype iterations” of the product, such as collaborations with infant formula manufacturers, will take between three and five years to bear fruit, while a full human milk product “is probably even further away,” Strickland said.
She also hopes to use Biomilq’s platform to visualize the institutional and physiological barriers to breastfeeding. Other breast milk experts want to see the same thing.
“What would be great would be to invest in breastfeeding support because if there was more breastfeeding, there would be less need for formula, need for donor milk or other options that are now being discussed,” Groff said. “That’s what we all want: healthy babies.”
Unlike the infant formula industry, which has heavyweights like Gerber and nestle, Perrin noted that “no company stands behind breast milk.” This makes it particularly difficult to mainstream breastfeeding safeguards, despite the efforts of breastfeeding advocacy groups.
In this complicated environment, Biomilq must also convince consumers to get involved with a breakthrough 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 breast milk is from a nutritional standpoint,” Perrin explained.
It’s such a problem that Strickland said one of her most common “stumper interview questions” for new hires is simply, “What is milk?”
Appropriately, Biomilq’s research will also fill existing gaps in our understanding of human milk. The company researches which aspects of breast milk its system is best able to produce.
“There are no two milk samples that are the same in terms of composition anywhere in the world,” said Strickland. To make a whole milk product rather than a hybrid formula, Biomilq needs to develop a production process that can make its product “consistent and stable batch to batch,” she added.
A tough time for startups
As well as entering a challenging and under-researched industry, Biomilq must also contend with growth difficulties common to startups. Strickland co-founded Biomilq with food scientist Michelle Egger, who left the company in March. Strickland, who was previously Chief Scientific Officer, took over as CEO.
Strickland declined to comment on the details of Egger’s departure, other than citing “some shifts in thinking about the company’s direction and overall strategy.”
Egger told CNBC she was advised not to comment further on Biomilq as she left the company.
Before leaving, Strickland’s partnership with Egger appeared to be a fluke. Strickland, who completed a postdoctoral fellowship in cell biology at Stanford University, was adept at the science, while Egger, who began her career at General Mills and helped develop Lärabar and Go-Gurt, had solid experience launching innovative food products.
As CEO, Strickland will likely place an even greater focus on Biomilq’s science. She wants the company to use its research as a “community exercise” by publishing, sharing and obtaining peer review of its findings, and collaborating with the scientific community.
Of course, Biomilq faces startup-specific challenges. The company was formed in the heyday of investor interest in lab-grown alternatives to mainstream consumer products: In 2013, the first lab-grown burger was developed by a scientist and publicly tasted, sparking broader interest in cell-focused products.
Funds flowed for a while: In addition to funds it received from Bill Gates’ investment firm, Biomilq also raised $21 million in its 2021 Series A rounds, Strickland said.
Now the tide could turn.
“Right now we’re in this weird biotech maelstrom where there’s a lot of concern about venture-backed initiatives like Biomilq,” she said, adding that Biomilq is increasingly focused on making sure the company “has enough working capital to survive what threatens”. like a tougher funding environment in the near future.”
Biotech funding hit a record high of $77 billion in 2021, according to Crunchbase data, but then declined 38.6% between 2021 and 2022. This decline is likely to be only exacerbated by the collapse of the Silicon Valley bank, where much of the US biotech is located. Though the collapse hit only a handful of biotechs directly, small biotechs could find it difficult to find another lender.
“It was a rapid growth phase, and now the whole ecosystem is going into a survival phase,” Strickland added.
Convincing parents will not be an easy task
Despite all the challenges, Strickland said that Biomilq’s path forward is still “quite similar” to that of other food technology companies “that are developing food based on a completely novel technology”. One of the biggest hurdles in bringing a product to market is government regulation, which is likely to be even stricter than the oversight other companies face given Biomilq specializes in infant nutrition.
Though it will be years before a product comes to market, Biomilq has entered discussions with the Food and Drug Administration, which will ultimately regulate the company, Strickland said.
“This phase is all about being open and transparent: ‘What do we want to do with it?'” she said. “Particularly within the FDA, they were severely affected by the formula shortage and recognized the need for innovation in this area.”
Groff added that even if Biomilq overcomes the “huge challenge” of FDA approval, the company will face an uphill battle convincing new parents to give their babies an unfamiliar product.
“It’s such a novel concept that it’s not entirely clear how consumers will react when they have this unusually crafted option available to them,” added Strickland.
But that doesn’t make Biomilq’s potential any less exciting for those involved in infant nutrition, like Groff and Perrin. Strickland said she is ready for any challenges ahead because the rewards have been worth it.
“It could really change the way we think about infant nutrition,” she said. “It’s really exciting to be a part of this conversation — even now.”