Nestlé and Helaina—a New York-based startup making bioactive found in human breastmilk via precision fermentation—have formed a multi-year partnership to expand understanding of the role of bioactive proteins in early‑life development.
Helaina, which is best-known for producing human lactoferrin via fermentation, noted that the partners would be looking at “bioactive proteins,” indicating that other ingredients in Helaina’s pipeline may be explored.
Founder and CEO Laura Katz told AgFunderNews that Helaina continues to expand partnerships with nutrition and supplement partners including GNC using its lactoferrin for adult nutrition products, but noted that introducing such ingredients in the infant nutrition space is a major undertaking,
“There’s a substantial amount of research into lactoferrin, which is the most abundant bioactive protein in human milk, and we have published 11 papers on our human lactoferrin. But with any novel technology brought into the food supply for infant nutrition, you’re still always going to do extensive research.
“We saw that same strategy with HMOs [human milk oligosaccharides, which are now widely used in higher-end infant formula products]. It took a lot of work in the early to mid-2000s to figure out how to make HMOs through fermentation, and there is still an extensive amount of research being published that continues to improve our understanding of their importance in early life nutrition.”
In adult nutrition, meanwhile, Helaina is also developing collaborations in women’s health, gut health, active nutrition, and hair growth, said Katz. “We’re learning a tremendous amount about the role of lactoferrin in helping to grow hair. We’re also running human clinical studies on the impact of our human lactoferrin for menstrual health and iron status. We also have some compelling pre-clinical data about the role of our human lactoferrin in the gut and on the immune system.
“In all of those preclinical studies, we always compare our product to bovine lactoferrin, and what we see consistently is that this [the human version] is a superior product.”
“Nestlé has always been at the forefront of advancing scientific knowledge on key nutrients and bioactives that are important during early life, including their interactions with the gut microbiome and the immune system. Collaborations with external partners such as Helaina, form an integral part of our broader open innovation strategy to deepen scientific understanding in this field, while gaining access to emerging technologies.” Isabelle Bureau‑Franz, Head of the Nestlé Product Technology Center for Nutrition & Health
Manufacturing and scale up
Helaina has now scaled up production capacity for its precision fermented human lactoferrin (brand name: effera) with co-manufacturing partners to the scale of metric tons, said Katz, who has struck deals with multiple commercial partners who have launched with effera to date. It is also working with Mitsubishi International Food Ingredients, although it cannot reveal details of the partnership at this stage.
Whey proteins such as beta-lactoglobulin, which is now made by several precision fermentation players, are smaller and less complicated to produce recombinantly, she claimed. “Lactoferrin is a large, highly complex glycoprotein protein and making that through fermentation at the scale we’re operating at will take time for other companies to accomplish.”
Human vs bovine lactoferrin
A bioactive protein found in breast milk and colostrum, lactoferrin is essential for iron balance, immune function, gut health, and a healthy inflammatory response. Helaina expresses it in a genetically engineered strain of yeast and has self-affirmed the ingredient as GRAS (Generally Recognized as Safe).
Several startups are producing bovine lactoferrin via precision fermentation for the adult nutrition market. However, human lactoferrin—which is structurally different to the bovine version—is seen by potential customers as a premium option, claimed Katz.
While some other startups including Eclipse Ingredients [AgFunder portfolio co] and All G are also working on human lactoferrin via precision fermentation, Helaina—which has raised $83 million in equity funding to date—is the most advanced.
Women’s health, gut heath, immunity, inflammation
A protein that binds and transports iron, lactoferrin is of particular interest to companies in the women’s health arena, given that many women are iron deficient, but experience digestive issues if they take iron supplements, said Katz.
While the innate immune system is built during infancy, the adaptive immune system is constantly evolving throughout the lifecycle, with a body of literature showing there are benefits to lactoferrin consumption throughout the human lifecycle, claimed Katz.
Based on the published clinical data, she said, customers could potentially make several claims around optimizing iron utilization, healthy gut function, healthy inflammatory response and maintaining a healthy immune system.
“What we’re finding in the market with some of the early adopters is a really keen interest in the bio-equivalency of our human milk protein to what’s found in human breast milk. That message is really resonating. It’s also easy to formulate with and plays well with several other key ingredients.”
According to Katz: “Our body produces lactoferrin throughout life and our lactoferrin levels fluctuate, especially as women, in response to estrogen, and there’s a lot of interesting applications within the world of women’s health. So we see a huge opportunity, like you’ve seen in the past with collagen or creatine: our bodies make this stuff, but supplementing with more has been demonstrated to show real benefits.”
Further reading:
🎥Totality Biosciences bets on plants to scale human milk oligosaccharides for a wider audience
Vivici raises $34m to expand animal-free dairy operation, plans move into lactoferrin market
Alpine Bio debuts ‘insanely soluble’ soy protein isolate and iron-rich lactoferrin made in soybeans
All G raises $6.6m, forms JV with Armor Protéines to scale human and bovine lactoferrin
