US Start-up Develops Breast Milk Substitute

tlwdotcom-The Land World
5 min readJun 17, 2022

The shortage of milk powder has intensified since Abbott, the largest U.S. milk powder supplier, closed its factories due to product safety concerns.

As early as last November, there were signs of a shortage of infant formula in the United States. In February of this year, Abbott, the largest milk powder supplier in the United States, recalled several infant formula milk powder products and closed its Michigan factory due to product safety issues, resulting in the “milk powder shortage” problem intensified.

It wasn’t until May 16 that the U.S. Food and Drug Administration announced that it would allow infant formula from overseas to enter the U.S. market. According to recent statistics from the United States, in late May, the shortage rate of infant formula milk powder in nine states including California, Florida, and Louisiana reached 90%. The national infant formula out-of-stock rate also climbed to more than 73%.

According to the U.S. Food and Drug Administration, since 2020, the agency has canceled thousands of routine inspections of infant formula factories due to the severe COVID-19 outbreak. According to inspection records, during an inspection last July, the U.S. Food and Drug Administration found that Abbott’s milk powder factory in Michigan had problems with water accumulation and lax sanitation procedures. Correction warning.

Since then, several children in the United States have been infected with bacteria and even died after eating Abbott’s formula milk powder. The U.S. Food and Drug Administration returned to the Abbott factory for a thorough investigation. In the end, many samples were tested positive in the factory.

The plant was subsequently shut down, and Abbott announced a recall of several problematic formulas. Since then, the shortage of domestic milk powder in the United States began to worsen and quickly turned into a full-blown crisis.

The current shortage of infant formula has prompted an urgent need to find alternatives on the market. While the U.S. has been trying to increase its supply of infant nutrition products, it has not solved the crisis. As a result, there is a scare of developmental and health problems for those children with specific metabolic needs.

The formula crisis in the United States underscores the seriousness of infant nutrition. Industry insiders point out that the monopoly of a handful of manufacturers over U.S. supplies has created a supply bottleneck, which should in fact provide more options for parents who are unable or unwilling to accept breast milk.

Cell-cultured and precision-fermented breast milk substitutes, while still niche, offer additional options for parents across the globe. The following 5 startups are working hard to provide sustainable alternatives to regular infant formula to ensure that every child can drink “breast milk”.

1. Turtletree Labs

Founders: Fengru Lin and Max Rye Country: Singapore

Funding to date: $39.4 million

Manufacturing Method: Cell Culture

A major development: from animal-free milk to human breast milk substitutes

Expected release: 2023

In 2020, Turtletree announced that it was seeking to partner with leading infant formula brands to manufacture human breast milk replacement products. At the time, it was the company’s commercial transition from developing animal-free milk.

In June 2021, the startup launched its first commercial product, a cell-cultured human lactoferrin. The ingredient has been shown to provide immunity and developmental benefits and is expected to be approved by food regulators, allowing Turtletree to disrupt the infant formula industry faster. The company seeks regulatory approvals in both Singapore and the United States.

2. Helaina

Founder: Laura Katz

Country: United States

Funding to date: $24.6 million

Manufacturing method: precision fermentation

A major development: Recreation of an immunologically equivalent protein previously found only in breast milk.

Expected release: unconfirmed

Helaina uses precision fermentation technology to produce a naturally equivalent solution of breast milk. After raising $20 million in Series A funding last November, the company is expanding its production technology and working toward commercialization.

Helaina uses the same technology used by alternative dairy startup Perfect Day, using yeast fermentation to recreate natural whey protein, which can be made into animal-free dairy products.

Helaina has successfully re-edited microbially produced breast milk proteins. These breast milk proteins have been clinically proven to increase infant immunity and will be used to produce the first infant formula.

3. Biomilq

Founders: Leila Strickland and Michelle Egger Country: USA

Funding to date: $24.5 million.

Manufacturing Method: Cell Culture

Major Developments: From Proof of Concept to Proof of Complexity in 2021.

Expected release: Within four years.

Biomilq was founded to disrupt the profit-driven infant formula industry by refocusing on parents and their children. Work on the project began in 2013, with a prototype launch in 2021. This makes Biomilq the first company to produce “cell cultured breast milk” outside the breast.

Bill Gates has more than once invested in this new startup founded and led by female entrepreneurs.

4. Wilk (BioMilk)

Founders: Arik Kaufman, Kobi Buxdorf and Tomer Aizen

Country: Israel

Funding to date: $1 million

Manufacturing Method: Cell Culture

Major development: In 2022, the patent for cell cultured breast milk will be obtained, and lactoferrin will be successfully replicated

Expected release: Initial samples 2023 Similar to Turtletree, Wilk was originally set up to investigate the possibility of cell-cultured milk. This is gradually expanding to human breast milk substitutes to enter the higher value global infant formula market. In 2021, the company will become the first public company in the cell culture dairy sector.

Following a successful patent application earlier this year, Wilk has submitted additional materials to protect its intellectual property and research and development. The company’s current focus is to determine the best way to maximize milk production from cell-cultured breast cells.

Just today, following the company’s successful production of lactoferrin from cell culture, Wilk CEO Tomer Aizen said the breakthrough brings the company one step closer to its goal of providing all babies with a protein that can only be found in breast milk. Comprehensive nutrition.

In addition to its benefits for formula-fed infants, lactoferrin is thought to have broader health benefits. Through further research and development, Wilk expects to be able to produce lactoferrin in unlimited quantities. It is unclear whether the startup will supply lactoferrin to partners outside the formula industry.

5. Me&

Founders: Saxena and Luis Malaver-Ortega

Country: Australia

Funding to date: unconfirmed

Manufacturing Method: Cell Culture

Significant Development: Unconfirmed

Expected release: unconfirmed

A new player in the field, Me& is launched to expand the benefits of breast milk while helping parents who cannot breastfeed. The startup is looking to use cell culture technology to capture and replicate the complex components of human breast milk to develop products that can replace traditional formula.

The global infant formula segment is expected to reach $125.2 billion by 2030. Being able to enter a market of this size is the dream of all these startups, but who among them will seize the opportunity to reach the other side? Let’s wait and see.

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