Nestlé’s new partnership with biotech startup Helaina signals a deeper push into next-generation ingredients that bring infant formula closer to the composition of human breast milk – a long-standing goal across the category.
While details on specific product applications remain under wraps, Helaina founder and CEO Laura Katz said the collaboration is primarily focused on early-life nutrition.
At the center of the partnership is lactoferrin, a bioactive protein that plays a critical role in infant health and is one of the most abundant functional proteins in human breast milk. Historically, the ingredient has been difficult to scale, produced only in small quantities from cow’s milk and subject to supply and pricing fluctuations.
Helaina uses precision fermentation to produce what it describes as a human-identical version of lactoferrin, marketed as effera. According to Katz, precision fermentation offers functional and supply chain advantages over traditional sources.
Effera’s stable production could be meaningful for large formula manufacturers when ingredient price swings complicate formulation and long-term planning. Katz noted that bovine lactoferrin prices can “change dramatically” by “hundreds of dollars a kilo,” making consistency a key unlock for broader adoption.
“The whole industry of infant formula is working to move towards as close as possible … to breast milk,” she added.
‘We did the fats, we did the sugars, now it’s the proteins’
The partnership also helps normalize the use of biotechnologies in formula, Katz said.
Bioactive proteins are the next frontier, she said, adding: “We did the fats, we did the sugars, now it’s the proteins.”
Infant formula makers have been steadily layering in bioactive-enabled ingredients – first fats, like omega-3s, then human milk oligosaccharides (HMOs) – to more closely replicate breast milk.
The progression of tech and ingredient production, coupled with growing clinical and commercial precedent, may ease concerns around consumer acceptance of such technologies, Katz said.
Helaina’s expertise in bioactive proteins and its ability to scale volumes to meet Nestlé’s infant nutrition needs is the next step in that evolution.
“Our goal as a company is to bring human bioactives to every baby and adult in the world,” Katz emphasized.
Building credibility and efficacy ‘in public’
The partnership also reflects a shared emphasis on scientific research and commitment to safety. Helaina has taken an intentionally transparent approach, publishing roughly a dozen scientific papers on its technology.
“We’ve basically built in public,” Katz said.
That research-first mindset made Nestlé a natural partner, she added, pointing to the food giant’s long-standing investment in nutrition science and ongoing research programs.
“Having somebody who really has the same vision as we do, as well as the same commitment to research, is really important,” Katz said.
Navigating regulatory pathways on a global scale
Still, bringing new ingredients into infant formula is as much about regulatory navigation as it is about R&D. Requirements vary significantly by region, particularly when it comes to clinical trials.
“Depending on where you go in the world, some regions require any new infant formula to go through a clinical trial. Some regions don’t,” Katz said.
As a result, commercialization timelines and distribution strategies will depend heavily on geography.
Helaina has already secured GRAs status for effera in the US, while its European expansion is still in progress, Katz said.
The company is also pursuing approvals in other major markets, with regulatory strategy serving as a leading factor in where products can launch, she added.
Delivering effera at scale
Like many startups, execution at scale is one of the biggest hurdles to meet global demand. Helaina says it has achieved lactoferrin production at large volumes through fermentation, a milestone Katz describes as foundational.
She said Helaina is producing metric tons of the protein today and has built the capability to scale further, positioning it to potentially become one of the largest lactoferrin producers globally.
Ultimately, the partnership reflects a dual priority shaping the infant formula industry: Maintaining rigorous safety and regulatory standards while continuing to innovate on a consistent supply of bioactives. These priorities are particularly urgent given recent formula recalls across CPG – from multinationals like Nestlé and Danone to smaller US brands like ByHeart.
“We need to make sure … our formula supply is safe, and we also need it to advance and make it closer to breast milk,” Katz said. “It’s not an ‘or,’ it’s an ‘and.’”
