But that may soon change as an emerging cohort of companies race to bring to market options that more closely resemble human milk, by leveraging cutting-edge technology, advanced nutritional research and a new mindset that prioritizes not just babies’ health, but also parents’ well-being.
Among the companies leading the charge is start-up Helaina, which uses precision fermentation to recreate immune-equivalent proteins previously only available in breast milk, BIOMILQ, which uses cellular technology to culture human mammary cells that lactate, and ByHeart and Bobbie, which are creating cleaner formulas free of heavy metals, pesticides and antibiotics commonly found in the packaged consumer goods.
In this episode of FoodNavigator-USA’s Soup-To-Nuts podcast, Helaina founder Laura Katz discusses how she is “moving the needle” for infant formula to be closer to breast milk with precision fermentation, and in doing so empowering caregivers to feel better about their feeding decisions. She also shares how a recently closed $20m series A fundraise will help Helaina scale. Finally, we take a closer look at the competitive landscape, including updates from other innovators and where there is still room to grow.
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Given the differences between traditional infant formula and breast milk, it is easy to see how breast-feeding is the gold standard in infant nutrition – but for a variety of reasons, it isn’t always an option for caregivers.
For those who can’t or choose not to breastfeed, Katz says she wants to bring to market a high-quality option that is as close to breast milk as possible – not just in terms of nutrition but other benefits as well.
“I learned very quickly that breastfeeding is not always the choice parents want. Some people don’t want to breastfeed. Some people can’t breastfeed for a lot of different reasons,” Katz said. “And I think that there is a lot of shame and stigma not being able to breastfeed, but we’re in an environment in which women in their careers are rapidly growing, which is exciting,” but also requires additional infant feeding options.
“So, I think part of the messaging that Helaina will bring to this world is that fed is best. As long as you’re feeding your baby, you are doing a great job,” Katz said.
And by creating an infant formula that is closer to breast milk, she adds, Helaina is helping caregivers feel more confident in their choice – whether voluntary or not – to feed their child formula.
That said, Katz recognizes that many of the infant formula options available currently are not the same caliber as breast milk. But, she says, technology – and specifically precision fermentation – has evolved so that it is possible now to recreate components of breast milk, just as it is possible to create components of dairy milk or animal protein without the animals.
“What we do at Helaina right now is we are recreating the proteins found in breast milk using precision fermentation. So, we train yeast to become little cell factories that then spit out proteins that look just like those found in breast milk and we’re taking those proteins that we’ve created and putting them into our own formula,” that combines other essential components sourced from other players, Katz said.
She explains there are many human proteins in breast milk, but Helaina is starting with one that conveys immunity by teaching the body how to fight against infections.
Scaling is time consuming and expensive
While precision fermentation is making possible what once was impossible, it is still expensive and time consuming, which is one reason why it may be a while before Helaina’s proteins are available on store shelves. But Katz says a recent $20m series A fundraise brings the company one step closer to producing its proteins at sufficient scale to feed the next generation.
The fundraise, which closed late last year, was co-led by Spark Capital and Siam Capital, with additional investment from Primary Venture Partners, Plum Alley Investments, and others, and will primarily go towards manufacturing and commercialization costs.
Katz explained that the money will partially go supporting existing team members but also scaling production, which requires significant ongoing research and development.
“We work in a lab scale fermentation system, so up to 10 liters, but 10 liters is not enough to feed a lot of babies, so we are currently in the process of scaling with partners as we don’t have our own manufacturing capabilities right now,” Katz explained.
She added that because fermentation doesn’t scale linearly, the company needs to test production at about ever 10x volume increase, which takes time and patience.
At the same time Helaina is scaling production, it is working closely with FDA to ensure the product meets rigorous safety standards for infant formula. Once it has FDA approval, Katz says, the company will have a better idea of when its product will be available.
The competitive landscape is large, but plenty of room for more players
As Helaina moves through the steps necessary to scale and go-to-market, several other players are also working with FDA to bring to market innovative new infant formulas that could dramatically change the competitive landscape.
Among those is BIOMILQ, which is culturing human mammary cells that lactate to create a whole human milk product that could be ready to go to market as early as this summer if it gains regulatory approval.
BioMilk, which recently rebranded as Wilk, is another bio-foodtech innovator that is using cell-based production to produce both human and animal milk from milk-producing mammary epithelial cells. The rebrand represents the company’s collaborative approach to “revolutionizing” the milk industry by replacing the ‘m’ in milk with a ‘w’ that stands for ‘we.’
Much like Wilk, Helaina doesn’t view competition from others in the $50b infant formula space as a bad thing, especially given its projected rapid growth in the coming five years when it is expected to reach $109b. Rather, Katz says, caregivers need more better options, which she says she is excited to bring to market and see others do as well.
Beyond infant formula to create a new category of consumer immunology
While Helaina currently is focused on the infant formula category, Katz sees significant potential for the technology and human proteins beyond babies. She explains that she wants to create an entirely new category of food immunology that will leverage precision fermentation to create proteins with immune boosting benefits.
This would include targeting aging consumers, those who need medically tailored meals, those who are battling chronic illnesses or more.
So even though there are still significant milestones to reach and hurdles to overcome, the promise of new technologies to help level-up the nutritional value of infant formula and other categories is one to watch.