Laboratory breast milk startup Biomilq aims to transform infant nutrition – if it can launch a product

In 2020, in a nondescript office building in Durham, North Carolina, a team of scientists used cells to recreate the sugar and protein found in breast milk.

A seemingly specialized evolution could, years later, change the way infant feeding is understood and distributed in America.

Biomilq, the company behind the breakthrough, has worked for nearly a decade to replicate the process of making breast milk — but outside the body. Its advance was made possible by hundreds of volunteers, who donated samples of their milk so that the company could build a cell bank large enough to begin its process of mass replication of milk.

Just two years after Biomilq’s spotlight moment, the potential benefits of the invention came into focus when several major infant formula brands were recalled, sending the entire industry into a tailspin, raising prices and putting new parents in a desperate bind.

More than a year after supplies first fell, a former FDA official said in late March that infant formula supplies remain vulnerable to disruptions and safety issues.

Formula shortages have exposed the fragility of the infant nutrition supply, which only underscores the importance of Biomilq’s vision and ability to meet need, According to its founder and CEO, Lila Strickland.

“The shortage of infant formula was inevitable because of the way we produce it in this country,” Strickland said. “When we have made all the food, to feed all the children, and that small number of plants… there will eventually be an event like this.”

While the crisis has highlighted the importance of formula milk supply, human milk experts, milk bank advocates and Biomilq all stress the same message: Breastmilk is best. But several American policies, including the lack of paid parental leave, make that an impractical option for many parents.

If Biomilq can get its scientific innovations to market and keep prices down, it has “the potential to be a game changer,” according to Marianne Perrin, a professor who studies human milk at the University of North Carolina Greensboro.

There is also an upside to the climate: many infant formulas are based on powdered cow’s milk, the production of which takes a significant 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 technologies are in place, Perrin believes it can be extended to other, larger markets, such as producing cow’s milk in a cell culture model.

“Technology has the potential to impact a wide number of industries,” she said.

But before Biomilq can do any of that, it will have to find its place in a historically contentious industry, navigate startup challenges and clear important regulatory hurdles.

It’s not clear what share Biomilq will take in the global infant formula market, which is expected to be worth more than $100 billion by 2032, especially given discussions of breastfeeding alternatives.

Biomilq is not intended to replace breastfeeding or infant formula, but proponents of both methods have opposed alternatives in the past. In order to create space in the industry, Biomilq will have to make it clear that its products are intended to align with the existing infant feeding ecosystem, said Perrin and Lindsay Groff, executive directors of the Human Milk Banking Association of America.

Strickland acknowledges that Biomilq falls “in this valley” between breastfeeding and formula – a fact that complicates its path to market. She said she eventually wants to support access to all infant feeding options.

Strickland said she has spoken with infant formula companies who want to know how Biomilq technologies can improve their existing formulas. The startup will likely take a “stepwise approach” to introducing its science through an “early nutritional product in partnership with one of these big companies,” Strickland explained.

Over time, she hopes to eventually create a product that has the same “full macronutrient profile” as breast milk, while meeting the “functional definition of milk from a composition standpoint.”

However, don’t expect to see Biomilq alongside Gerber products anytime soon. Even “simpler, prototype iterations” of its product, such as collaborations with infant formula companies, will take three to five years to fruition, Strickland said, while a whole human milk product “is probably even further away.”

She also hopes to use the Biomilq platform to highlight the institutional and physiological barriers to breastfeeding. Other breast milk experts want to see the same thing.

“What would be great if there was an investment in breastfeeding support, because if there was more breastfeeding, there would be less need for formula, or need for donor milk, or whatever other options are being thrown around now,” Grove said. “This is what we all want: healthy babies.”

Unlike the infant formula industry, which includes heavyweights like Gerber and NestlePerrin noted that “there is no company behind breast milk.” This has made devoting protections to breastfeeding particularly difficult, despite the efforts of breastfeeding advocacy groups.

Amid this complex landscape, Biomilq will also have to convince consumers to join a leading product in an industry that lacks research and public understanding. Breastmilk is woefully under-studied — so much so that it’s hard to even say what breastmilk is He is From a nutritional point of view,” Perrin explained.

It’s such a problem that Strickland said one of the common “difficult interview questions” for new hires is simply: “What He is Milk?”

Appropriately, Biomilq’s research will also fill gaps in our understanding of human milk. The company is researching which aspects of human milk are most suitable for its production system.

“No two samples of milk ever, anywhere on the planet, are the same from a composition point of view,” Strickland said. She added that to create a whole milk product, rather than a hybrid formula, Biomilq would have to create a production process that could make its product “consistent and consistent for every batch.”

In addition to entering a challenging, research-less industry, Biomilq also has to grapple with growth pains common to startups. Strickland founded Biomilq alongside food scientist Michelle Egger, who left the company in March. Strickland, previously the chief scientific officer, has taken over as CEO.

Strickland would not comment on any details of Iger’s departure, other than citing “some shifts in thinking in the company’s direction and overall strategy.”

Iger told CNBC that she was advised not to comment further on Biomilq because she had left the company.

Before leaving, Strickland’s partnership with Egger seemed like a coincidence. Strickland, who completed a postdoctoral fellowship in cell biology at Stanford, has a handle on that science, while Egger, who began her career at General Mills and helped develop Lärabar and Go-Gurt, has solid experience providing innovative nutritional products. .

As CEO, Strickland will likely bring a deeper focus to Biomilq’s science. She wants the company to use its research as a “community exercise,” by publishing, sharing, and seeking peer review of its findings, as well as engaging with the scientific community.

Biomilq certainly has startup challenges. The company emerged at the height of investor interest in lab-grown alternatives to popular consumer products: In 2013, the first lab-grown burger was developed and publicly tasted by a scientist, sparking broader interest in cell-oriented products.

The money has been pouring in for some time: In addition to money received from Bill Gates’ investment firm, Biomilq also raised $21 million in Series A rounds in 2021, Strickland said.

Now, the tide may be turning.

“Right now, we’re in this strange spiral in biotech where there’s a lot of angst about venture capital-backed initiatives like Biomilq,” she said, adding that Biomilq is increasingly focused on ensuring it has “enough operating capital to afford what it’s looking at.” Such as a more difficult financing environment in the near future.”

Biotech funding hit a record $77 billion in 2021, according to Crunchbase data, but then fell 38.6% between 2021 and 2022. That downturn is likely to be exacerbated by the collapse of Silicon Valley Bank, where a wide range of technology is located. American Vital Banking Corporation. Although the crash directly affected only a few biotech companies, smaller biotech companies may be hard-pressed to find another lender.

“It was a rapid growth phase, and now the entire ecosystem is shifting into a survival phase,” Strickland added.

For all of Biomilq’s challenges, Strickland said its path forward still looks “much like” other food technology companies “developing foods from entirely new technology.” One of the biggest hurdles it faces in bringing a product to market is government regulations, which are likely to be more stringent than the oversight other companies face, since Biomilq is in the baby feeding business.

Strickland said that while we are still years away from bringing a product to market, Biomilq has begun talks with the Food and Drug Administration, which will eventually regulate the company.

“Mostly at this point,” she said, “it’s about being honest and transparent about: What do we envision this becoming?” “Within the FDA in particular, they were really impressed by the lack of formula and recognized the need for innovation in this area.”

Even if Biomilq overcomes the “significant challenge” of FDA approval, Grove added, the company will face an uphill battle persuading new parents to feed their babies an unfamiliar product.

“It’s such a new concept that it’s not entirely clear how consumers will respond when this option is available produced in such an unusual way,” Strickland added.

But none of this makes Biomilq’s potential any less exciting for those like Groff and Perrin, who study infant nutrition. Strickland said she’s ready to take on any challenges in the future, because the reward is worth it.

“It could really change the way we think about feeding children,” she said. “It’s really exciting to be a part of that conversation — even at this point.”