Studies have shown that baby formula is no match for human breast milk when it comes to nourishing babies and boosting their immune systems.
But one company is trying to create the first type of formula to have human proteins in it, in a move that could spark a wave of innovation across the industry.
The CEO of US-based Helaina spoke at Web Summit in Lisbon earlier this month on the future of food, and talked up her company’s ambitions to transform an industry she said had failed to innovate for decades, leaving parents of newborns with insufficient options.
The World Health Organization (WHO) advocates breastfeeding children exclusively for their first six months, pointing to a range of benefits, such as protection against gastrointestinal infections, boosts to the immune system, and overall improved nutrition.
But many parents feed their babies formula - whether by choice or necessity - and as it is most commonly made from cow milk, it doesn’t have the same health benefits as human breast milk.
While formula in both the US and Europe is required to meet certain nutritional standards, ensuring it can give the baby all the nutrients it needs to grow and stay healthy, breast milk is highly complicated and most likely impossible to be replicated with a formula.
What Helaina is trying to do is to incorporate human proteins into its formula, to give as many of the benefits associated with breast milk as possible.
“There are really special properties of proteins in breast milk, with how they help to support the immune system as the baby grows,” Laura Katz, the founder and CEO of Helaina, told Euronews Next.
“It's very specific to humans. With a human drinking human milk, we're getting human proteins that our bodies can recognise and use”.
The composition of breast milk is complex and dynamic, adapting itself over time to the changing needs of the growing baby. Its unique biology isn’t fully understood by the scientific community yet, so replicating breast milk entirely cannot currently be done, Katz explained.
Brrewing up a new formula for human-like milk
What can be done, Katz said, is replicate the proteins found in human breast milk.
“How we do this is similar to how you make beer. So when you make beer, you take yeast, you give it nutrients, and you give it all the things it needs to grow. You ferment it. And then that yeast makes alcohol”.
The scientists at Helaina are able to programme the yeast to make the human proteins they want to add to the formula, she explained.
They give the yeast the nutrients it needs to grow and ferment.
“And when they grow in the fermentation, they start to spit out proteins that are identical to what's in breast milk,” she said.
“These yeast are kind of like little cell factories and there's millions of them in one tank. And all these little cell factories, once they're triggered or turned on, they're going to be spitting out the proteins”.
The company is still developing its product, which will have to go through a clinical study before it can be approved for sale.
The company, which is based in New York City, has received investment of more than $25 million (€24.9 million) so far.
‘Lack of innovation for the last 50 years’
For parents in the US who rely on baby formula, a shortage earlier this year highlighted the need for change in the industry.
US president Joe Biden ordered emergency airlifts of formula from Europe, while invoking decades-old wartime powers to speed up production at home.
That was a result of health giant Abbott Nutrition issuing a safety recall for formula across the US, which exacerbated already stretched supply chains.
For Katz, that scare for millions of parents was just the latest issue in an industry that she says has seen a lack of innovation for “the last 30, 40, 50 years”.
“We see currently three players own most of the market and they have their own manufacturing facilities, so when an issue happens with a facility, as we saw with the Abbott facility, that one facility was making 25 per cent of the US supply of infant formula,” she said.
“So if something happens to one player, the whole supply gets seriously impacted. What that means is parents don't know what to feed their baby, which is ultimately the biggest concern”.
Although Helaina has big plans, it won’t be solving the supply issues immediately.
It is aiming to be the first company to sell formula with human protein, which brings “unique challenges” in terms of working with regulators and scaling, Katz explained.
Other companies have tried to do similar things in the past, but Katz believes her start-up has appeared at the right time.
“There are a few things that we've benefited from over the past few years that didn't exist 10, 15, 20 years ago - advanced gene editing tools that actually allow us to create the proteins, exactly how they're found in humans. Without these tools, we wouldn't be so successful”.
While securing capacity for manufacturing has been another difficulty, Helaina is starting to find more options, she said, especially as other companies have started seeking regulatory approval for their own human proteins.
Katz told Euronews Next that Helaina was also in talks with a “handful” of companies in Europe, a region she believes is showing “a little bit more advanced thinking on infant formula” than in the US.
“So there's a big appetite for what we're doing, which is exciting,” she said.