Soja: ROSARIO
$336.000 -0.74%
Maíz: ROSARIO
$216.000 -0.92%
Trigo: ROSARIO
$253.500 0.12%
By Agroempresario.com
In a landmark achievement for biotech and nutrition, New York-based startup Helaina has successfully scaled the production of human lactoferrin through precision fermentation to metric-ton levels, equivalent to 10 million servings per production run. This development positions the company as a global leader in bioactive protein production and reshapes the way the food, wellness, and women's health industries approach functional ingredients.
By partnering with multiple commercial brands, including Kroma Wellness, Levelle, Healthgevity, Kepos, and Joel Greene’s Young Gut Ultra, Helaina is introducing its flagship ingredient, effera (its brand of recombinant human lactoferrin), into everyday products like beverages, powders, gummies, and supplements. In parallel, the company is forging strategic alliances, including a notable partnership with Mitsubishi International Food Ingredients, signaling its readiness to enter international markets.
At the core of Helaina’s innovation is the precision fermentation of lactoferrin, a complex glycoprotein naturally found in human breast milk and colostrum. This protein plays vital roles in iron regulation, immune modulation, gut health, and inflammatory balance throughout the human lifecycle.
What makes Helaina’s achievement noteworthy is the successful scaling of a highly intricate human protein. Unlike simpler molecules such as beta-lactoglobulin, commonly produced by fermentation startups, lactoferrin is large and glycosylated, requiring advanced expression systems. According to Laura Katz, founder and CEO of Helaina, this proves that the biotech industry is entering a new era:
“We aren’t just making a simple molecule; we are producing one of nature’s most sophisticated proteins at industrial scale.”
While other startups are developing bovine lactoferrin through similar methods, Helaina distinguishes itself by recreating the human version, which shows superior bioequivalence. Bovine lactoferrin, extracted from cow’s milk, is structurally different and often triggers immune reactions in humans.
“We’ve shown through clinical studies that effera does not generate antibodies in humans, unlike bovine lactoferrin,” Katz explained. “This means our product remains in the body longer and performs better, particularly in iron absorption, immune resilience, and gut balance.”
This scientific differentiation opens new market opportunities. With bovine lactoferrin being scarce and expensive to purify, Helaina’s approach offers both a functional and economical solution.
One of the advantages of effera is its formulation flexibility. According to Katz, the ingredient is shelf-stable, nearly tasteless, and highly bioavailable even at low doses. Its applications range from fortified yogurts and energy bars to capsules and functional drinks.
Kroma Wellness, one of Helaina’s commercial partners, has already launched a product combining effera with 2’-FL human milk oligosaccharides, marketing it as “the first colostrum made for humans.” This product taps into growing demand for gut health and immune-boosting ingredients grounded in clinical science.
Other launches from Levelle, Kepos, and Healthgevity have also targeted sectors such as women’s health, sports recovery, and digestive wellness, where the role of lactoferrin is particularly impactful.
Lactoferrin’s natural role in regulating iron absorption makes it a powerful solution for women, who are disproportionately affected by iron deficiency. Traditional iron supplements often cause digestive distress, while lactoferrin offers a gentler and more effective alternative.
“Because our lactoferrin levels fluctuate, especially in women due to hormonal changes, supplementation can support optimal wellness through different life stages,” said Katz. She compares its market potential to the rise of collagen and creatine, both endogenous compounds now widely adopted in wellness routines.
Moreover, Helaina is conducting animal and human trials exploring synergies between lactoferrin and creatine for muscle recovery, a key interest in the active nutrition space.
The traditional association of lactoferrin with infant formulas is quickly expanding. Research now shows its presence and role in the adult microbiome, saliva, mucosa, and even the brain, underscoring its function in pathogen defense, cognitive support, and inflammation regulation.
“We’re evolving beyond the idea that lactoferrin is just for babies,” Katz said.
“It’s found anywhere the body needs immune defense. And as we age, we produce less of it.”
According to Paola Delgado, Helaina’s COO, the company’s formulations are designed to restore and support the body’s natural balance, especially as endogenous lactoferrin production declines with age.
To date, Helaina has raised $83 million in equity funding, making it the most advanced startup in the human lactoferrin space. While others like Eclipse Ingredients and All G are entering the field, Helaina has taken the lead with GRAS self-affirmation, industrial scalability, and early commercial traction.
Katz emphasizes that the company isn’t just substituting bovine lactoferrin—it’s creating an entirely new category of human-compatible bioactives. “We’re building a platform for the future of functional ingredients, inspired by what the body already knows,” she said.
Future product lines may include other human milk-derived proteins and compounds with clinical differentiation. For this, Helaina is investing in academic partnerships and internal R&D, with a pipeline centered on gut health, immunity, and inflammation control.
With partnerships already active across the United States, Helaina’s alliance with Mitsubishi International Food Ingredients suggests plans for Asian market expansion. The company is also exploring ingredient licensing models and co-branded formulations, allowing other functional food and supplement companies to leverage the benefits of effera.
Katz concludes:
“This is only the beginning. We’re proving that precision fermentation can produce complex, clinically valuable molecules. And more importantly, that these molecules can improve how people feel, function, and flourish.”
