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Helaina Scales Manufacturing of effera Lactoferrin to Metric-Tons Level

Producing complex proteins to commercially impactful volumes via precision fermentation has long been a significant hurdle for the industry.

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By: Sean Moloughney

Editor, Nutraceuticals World

Photo: mary_markevich | AdobeStock

Helaina, which has developed a proprietary precision fermentation process to develop bioactive proteins, announced it has scaled its manufacturing for effera, a bio-identical form of lactoferrin, to the metric tons level.

Each production run now yields over 10 million efficacious servings, a scale that places Helaina among a select group of companies to master the commercial-scale production of a large and complex bioactive protein. AgFunderNews first reported on Helaina’s milestone.

Lactoferrin is a highly complex glycoprotein, approximately four times larger than commodity proteins like beta-lactoglobulin. Producing such a molecule with precision outside the human body has long been a significant hurdle for the industry. Helaina’s breakthrough demonstrates that precision fermentation can move from theoretical promise to real-world impact, the company said, enabling the delivery of high-value, structurally complex proteins at industrial volumes.

“The promise of precision fermentation has always been clear, but the unspoken challenge was whether the technology could handle truly complex proteins in commercially impactful volumes,” said Laura Katz, founder and CEO of Helaina. “This milestone proves that it can. We aren’t just making a simple molecule; we are producing one of nature’s most sophisticated proteins. This is next-generation nutrition, built for the human body, and ready for commercial markets.”

Transforming R&D into Commercial Impact

Helaina’s $45 million Series B round from September of last year has brought total venture funding to $83 million and has accelerated its evolution from an R&D-focused company to a commercially driven enterprise.

Scaling production has fueled rapid adoption among consumer brands. In the last six months, effera has been launched in six consumer products across categories including women’s health, digestive wellness, and active nutrition. Additional launches are in progress for later this year, with demand closely following the company’s supply of bioactives, the company said.

effera is a bio-identical lactoferrin, a bioactive protein found in breast milk and colostrum that is essential for iron balance, immune function, gut health, and a healthy inflammatory response. Unlike animal-derived or animal-equivalent alternatives, effera is structurally and functionally equivalent to the version naturally produced in the human body. This eliminates biological friction, improving tolerability and performance while offering a clinically supported alternative to bovine-based proteins.

“Consumers are looking for real innovation — ingredients that do more and work better,” Katz said. “By aligning with human biology instead of approximating it, we’re creating a new standard in nutrition. And now, we’re proving we can produce it in volumes to meet global demand, even with the most complex and valuable proteins.”

At SupplySide West last October, Katz told Nutraceuticals World her company has focused its commercial strategy on three primary platforms: women’s health, active nutrition, and healthy aging. She noted that lactoferrin’s ability to regulate iron and support microbiome health makes it particularly suited to addressing physiological shifts associated with perimenopause and menopause. “Our needs are evolving daily,” Katz said. “Effera has several roles to play there that we’re really just starting to understand — especially around energy, mood, and fertility.”

In the active nutrition space, Helaina is initially targeting more serious, outcome-focused athletes and biohackers, but Katz anticipates expansion into broader consumer segments. “Iron is so critical for performance,” she said. “Effera can help not just elite athletes, but everyday women who want to feel their best.”

For healthy aging, Helaina sees effera’s microbiome-modulating effects as a promising tool for supporting cognition via the gut-brain axis, particularly among adults in midlife. “The gut starts to change in your 40s and 50s,” Katz noted. “That’s where we think the opportunity is, especially as it relates to cognitive function.”

Helaina published its first clinical study in the International Journal of Toxicology last summer, demonstrating effera’s safety in healthy adults. More targeted research is planned, including studies in female populations and athletes. “Healthy adult work is great,” Katz said, “but if we can run something in women or athletes, the data becomes much more interesting.”

Beyond Lactoferrin: Platform Built for Future Bioactives

While effera is the company’s current focus, its ambitions extend beyond lactoferrin. Built on a proprietary platform for producing human bioactive proteins found in colostrum and breast milk, Helaina’s long-term goal is to replicate other high-value proteins with demonstrated clinical relevance. “We’re doing our own internal work, but we’re also looking to partner with others who want to develop specific ingredients,” Katz said.

She also pointed to the company’s internal machine learning platform as a driver of Helaina’s rapid R&D progress. “The speed at which we’ve worked and the scale we’ve achieved wouldn’t have been possible without the ML we’ve built,” she said, adding that accelerating development timelines is essential for food-tech startups. “The food industry moves slowly. If you can reduce time, it makes a big impact.”

As interest grows in personalized nutrition, Katz sees bioactive proteins like effera as uniquely suited to the task. “We call them adaptive nutrients,” she said. “They do what your body needs, when you need it. That’s already a level of personalization.”

Helaina’s ability to scale effera to industrial volumes may mark a turning point for both precision fermentation and functional nutrition. “The best thing to do when you’re starting out commercially is to stay focused. And that’s exactly what we’re doing with effera — doing one thing really well.”

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