December 5, 2023

Mother holding newborn baby lying in hospital bed.

Comments | E+ | Getty Images

In a nondescript office building in Durham, North Carolina, in 2020, a team of scientists uses cells Rebuilds sugars and proteins in breast milk.

The seemingly niche development could change the way infant nutrition is understood and distributed in the United States years from now.

Biomilq, the company behind the breakthrough, has been working for nearly a decade to replicate the process of making human milk — but outside the body. Its progress was made possible by hundreds of volunteers who donated samples of their milk so the company could build a cell bank large enough to kickstart its process of replicating milk on a large scale.

Just two years after Biomilq’s brilliant idea, the invention’s potential benefits came into focus when several major brands of infant formula were recalled, throwing the industry into turmoil, driving up prices and leaving the New parents are in a desperate situation.

U.S. infant formula supplies remain vulnerable to disruptions and safety concerns, a former Food and Drug Administration official said in late March, more than a year after supplies first fell short.

Formula shortages have exposed the fragility of infant nutrition supply, further underscoring the importance of Biomilq’s vision and its potential to meet demand, According to its co-founder and CEO Leila Strickland.

“Because of the way we produce in this country, infant formula shortages are inevitable,” Strickland said. “When we’re making all of our food, feeding all of our babies, and there’s so little plant life…eventually something like this is going to happen.”

While the crisis has highlighted the importance of a resilient formula supply, breast milk experts, breast milk bank advocates and Biomilq are all emphasizing the same message: breast milk is best. But many policies in the U.S., including the lack of paid parental leave, make that an unviable option for many parents.

If Biomilq can bring its breakthrough science to market and lower its price, it “has the potential to be a game changer,” says Maryanne Perrin, a professor at the University of North Carolina at Greensboro who studies breast milk.

Climate benefits, too: Many infant formulas rely on cow’s milk, producing cause significant environmental damage. With its climate-friendly potential, Biomilq secured $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 can expand into other, larger markets, such as milk production in cell culture models.

“This technology has the potential to impact a large number of industries,” she said.

But before Biomilq can do any of this, it must find its place in a historically contentious industry, address entrepreneurial challenges and clear significant regulatory hurdles.

Where is Biomilq suitable for?

It is unclear what share Biomilq will have in the global infant formula market, which is expected to gain weight Over $100 billion by 2032especially given debate Alternatives to breastfeeding.

Biomilq is not intended to replace breastfeeding or infant formula, but proponents of both have opposed alternatives in the past. Perrin and Biomilq executive director Lindsay Groff said that in order to carve out space in the industry, Biomilq must make it clear that its products are designed to fit within the existing infant nutrition ecosystem American Breast Milk Storage Association.

Strickland acknowledges that Biomilq sits in a “low point” between breastfeeding and formula — a reality that has complicated its path to market. She said she ultimately wants to support access to all infant nutrition options.

Strickland said she has spoken to infant formula companies who want to see how Biomilq’s technology could improve existing formulas. The startup will likely take a “step-by-step approach,” Strickland explained, presenting its science by “partnering with one of the larger companies to launch an early-life nutrition product.”

Over time, she hopes to eventually create a product that has a “full macronutrient profile” like breast milk while meeting “the functional definition of milk from an ingredient perspective.”

Don’t expect to see Biomilq alongside Gerber products anytime soon, though. Even “simpler prototype iterations” of its products, such as partnerships with infant formula companies, take three to five years to come to fruition, and full breastmilk products “maybe even longer,” Stein said. Rickland said.

She also hopes to use Biomilq’s platform to bring awareness to the institutional and physiological barriers to breastfeeding. Other breast milk specialists want to see the same thing.

“It would be great if there was an investment in breastfeeding support, because if there was more breastfeeding, there would be less need for formula, less need for donor milk or any other option that is being presented now,” Grove said. said Grove. “That’s what we all want: healthy babies.”

Unlike the infant formula industry, which includes Gerber and Nestle, Perrin points out that “there is no company behind breast milk”. This makes breastfeeding protections particularly difficult, despite the efforts of breastfeeding advocacy groups.

In this complex situation, Biomilq must also convince consumers to use a breakthrough product in an industry that lacks research and public understanding.Breast milk is sadly understudied — so much so that it’s hard to even say what breast milk is yes From a nutritional standpoint,” Perrin explained.

Strickland says one of the “interview questions” she often asks new hires is this one: “What? yes milk? ”

Fittingly, Biomilq’s research will also fill existing gaps in our understanding of breast milk. The company is investigating which aspects of its system are best suited for producing breast milk.

“From a compositional standpoint, no two samples of milk anywhere on Earth are the same,” Strickland said. To produce whole milk products, rather than mixed formula, Biomilq had to create a production process that would make its products “consistent and stable from batch to batch,” she added.

Tough times for startups

In addition to entering a challenging and under-researched industry, Biomilq had to navigate the usual growing pains of a start-up. Strickland founded Biomilq with food scientist Michelle Egger, who left the company in March. Strickland, who previously served as chief scientific officer, took over as CEO.

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

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

Before leaving, Strickland’s partnership with Eger seemed to have been an accident. Strickland completed her postdoctoral fellowship in cell biology at Stanford and can handle the science, while Eger, who started her career at General Mills and helped develop Lärabar and Go-Gurt, has a wealth of experience in introducing innovative food products. experience of.

As CEO, Strickland will likely take Biomilq’s science more seriously. She wants companies to treat their research as a “community activity,” by publishing, sharing and seeking peer review of their findings, as well as engaging with the scientific community.

To be sure, Biomilq faces challenges unique to startups. The company emerged during the heyday of investor interest in lab-grown alternatives to common consumer goods: in 2013, First lab-grown burger developed and tasted in public Initiated by a scientist, sparked widespread interest in cell-directed products.

For a while, the money was flowing: In addition to the cash it received from Bill Gates’ investment firm, Biomilq raised $21 million in a Series A round in 2021, Strickland said.

Now, the tide may be turning.

“Right now, we’re in this weird vortex in biotech where people are very anxious about venture-backed initiatives like Biomilq,” she said, adding that Biomilq is increasingly focused on making sure it has “enough working capital to withstand what is happening such as a more difficult financing environment in the near future.”

Biotech funding hits record $77 billion in 2021 Crunchbase data, but then decline by 38.6% between 2021 and 2022.This decline may only get worse with the collapse of Silicon Valley Bank, which A large number of US biotech companies received financial support. Even though the closures directly impacted only a handful of biotech companies, it may be difficult for small biotech companies to find another lender.

“It was a phase of rapid growth, and now the whole ecosystem is shifting to a survival phase,” Strickland added.

Convincing parents is not easy

For all the challenges Biomilq faces, Strickland said its path forward still looks “very similar” to other companies in the food tech space, “developing food with a completely new technology.” One of the biggest hurdles to bringing a product to market is government regulation, which may be tougher than other companies face because Biomilq is in the infant feeding business.

While it’s still several years away from bringing a product to market, Biomilq has already begun talks with the Food and Drug Administration, which will eventually regulate the company, Strickland said.

“At this stage, it’s mostly about candor and transparency: ‘What do we envision this going to be?'” she said. “Particularly within the FDA, they were really affected by the formula shortage and recognized the need to innovate in this space.”

Groff added that even if Biomilq overcomes the “enormous challenge” of FDA approval, the company will still face an uphill battle convincing new parents to feed their babies an unfamiliar product.

Strickland added: “It’s such a novel concept that it’s not very clear how consumers will react when they have this choice produced in such an unusual way.”

But for those who study infant nutrition like Groff and Perrin, Biomilq’s potential is undiminished. Strickland said she is ready for whatever challenges lie ahead because the rewards are worth it.

“It could really change the way we think about feeding babies,” she said. “It’s really exciting to be part of the conversation – even at this stage.”

What's Behind America's Baby Formula Crisis?