Dairy-free infant formula developed by Brazilian startup mimics composition of maternal breast milk

The biotech based at MIT is developing bioactive versions of the product using the same technique as breweries and pharmaceuticals that produce biologics.

By Elton Alisson  |  Agência FAPESP – A technique used in beer and wine production, and deployed by the pharmaceutical industry to make biological drugs such as insulin, has been leveraged by a startup founded by Brazilians to develop infant formulas that mimic human breast milk.

By means of precision fermentation using microorganisms genetically modified to produce proteins, enzymes and other compounds, researchers at the biotech Harmony Baby Nutrition are producing components biologically identical to those found in breast milk.

The startup, based at the Massachusetts Institute of Technology (MIT) in the United States, has used these components to develop products whose simplest composition is at least 64% biologically identical to breast milk, according to the company’s founders.

“We’re creating bioactive infant formulas that are both nourishing and mimic breast milk’s function of protecting babies in the initial phase of their lives when their immune system is only just starting to develop. None of this will be a substitute for breastfeeding, of course,” said Wendel Afonso, the firm’s CEO, in a talk delivered during the second Brazilian deep tech forum hosted on June 13 at Cubo Itaú in São Paulo city by Wylinka, an innovation and business agency. The event was supported by FAPESP.

According to Afonso, infant formulas and any other product marketed as an alternative to breastfeeding serve only as nutrition, since the technology used to make them destroys the proteins in cow’s milk, from which 95% of infant formulas are made.

Conventional spray drying is performed at almost 200 °C, and the products are also pasteurized, destroying or denaturing all the proteins. Moreover, typical infant formula has adverse side effects, above all because the main ingredient is cow’s milk, he explained.

“In the U.S., 90% of babies will consume infant formula from the age of six months or even younger because their mothers have to return to work two or three months after giving birth. One in five babies will have some kind of reaction, as many studies have shown, and there are no alternatives because the industry lacks the technology,” he said.

Revolution in the sector

The infant food market is estimated at more than USD 100 billion and has remained practically unchanged for more than a century. The same technology has been used to make infant formula for more than 150 years, according to Afonso.

“Infant formula is based on cow’s milk [which accounts for about 95% of the product]. Our challenge was how to shake up this market, which won’t be spared by the revolution that’s happening in the food industry thanks to plant-based products,” he said.

To achieve this goal, the firm’s researchers decided to use recombinant proteins and precision fermentation to culture components of breast milk.

The process starts with the selection of microorganisms into which to insert the DNA of proteins similar to those found in breast milk. These microorganisms are fed into a fermenter or reactor similar to a tank for brewing beer in order to produce the proteins efficiently on a large scale. A microbial filtration system of pharmaceutical quality then separates and purifies the proteins.

“The microorganisms are never removed from the reactor. They function like factories, constantly producing the proteins of interest, which are considered biologically identical to those found in breast milk,” Afonso said.

The startup has produced two generations of dairy-free products based on these components and is about to launch them in the U.S.

It also plans to launch a product in Brazil, where one of its laboratories is located, in the capital of Minas Gerais state, Belo Horizonte. This unit is responsible for developing formulations.

“We develop the components at our lab in Boston, USA, and send them to Brazil for use in the formulations. We also have a lab in Hong Kong,” he said.

Patient capital

The topics discussed during the second Brazilian deep tech forum included the issues of instruments for investing in these startups so that they can bring their innovations to market, alongside the legal certainty required for them to take risks and grow.

“One question is how to give business environments, deep techs and researchers more security and agility, and less bureaucracy, to make sure innovation can happen,” said Paulo Mendonça, Wylinka’s manager for partnerships and relationships. 

The event featured a panel session on innovation and investment in which participants said patient capital alone will not be sufficient to develop these science and technology-intensive startups, stressing the importance of investing in the team and facilitating access to intellectual capital in order for the R&D to make progress until impactful solutions are forthcoming.

Another challenge discussed at the meeting was the problem of unstable funding and investment volatility due to economic swings and regulatory uncertainty, all of which hinders planning, scalability, and launches of innovations.

Diego Dutra, an executive representing Cromai, a startup supported by FAPESP’s Innovative Research in Small Business Program (PIPE), stressed the importance of investors’ belief in the startup’s business strategy to bring innovations to market.

“Cromai has succeeded only because it didn’t begin with soybeans but with sugarcane,” he said.

Although the soybean market is more profitable, it would have been less strategic for Cromai’s entry because of the typical customer’s behavior. If the investors had not helped the researchers and entrepreneurs choose the right segment in which to enter the market, the startup would probably have failed before its business model was validated, Dutra opined (read more at: agencia.fapesp.br/50441).