Q&A: Helaina founder talks reproducing breast milk proteins for mass consumption

“It featured stories from people of all walks of life—new parents, athletes and cancer patients—going to great lengths to get the powerful nutritional benefits of breast milk proteins for themselves or their loved ones,” she said.

Katz, a food scientist by training, began to explore the possibility of replicating these highly coveted bioactive compounds for mass consumption and in 2019 founded Helaina as the first company to offer the immunity properties of breast milk for all stages of life. Since then, the startup has raised over $38 million on its mission to push the boundaries of nutrition by providing “functional compounds inspired by the body’s natural intelligence”.

Helaina will be featured as one of this year’s NutraIngredients-USA Start-up Stars​ at the upcoming Sports and Active Nutrition Summit (SANS)​ in San Diego, CA from Feb. 12 to 14.

NIU: How did Helaina get its start? What was your path to market?​

LK: We have assembled a world-class team of experts in food science, nutrition and engineering, working together to bring novel ingredients to the world.

The team evaluated the scientific data on bioactive proteins in breast milk and produced by the human body for the most effective, research-backed options to bring to market. We homed in on the human version of Lactoferrin, one of the most widely studied ingredients of our time. It is a multifunctional molecule highly concentrated in colostrum and found throughout the body.

Ideation transitioned to the lab, where the team ran thousands of experiments to develop Helaina’s tech stack for making human proteins outside the body and successfully replicated Effera, Helaina’s Human Lactoferrin. After achieving lab-scale manufacturing, the team ran commercial manufacturing campaigns to ensure the process could be replicated with high quality. The manufactured product was tested for quality, safety and functionality.

We ran our first clinical study to ensure Effera’s safety for adults in 2023 and will bring the ingredient to market in 2024. To accomplish this, we have raised over $38M dollars in a seed and Series A round from leading investors. 

NIU: Could you tell us a bit more about Helaina's biotech/precision fermentation platform? How do you reproduce human proteins found in breast milk?​ 

LK: Helaina’s process to manufacture Effera is similar to how the pharmaceutical industry makes human insulin. In the simplest terms, we take a specific strain of yeast and teach it to produce our protein of interest during the fermentation process. We do this by introducing a new operating system to the yeast—this operating system is human DNA. With the human DNA in place and an optimized environment for fermentation, the yeast expresses Effera. The final product is a highly pure and supremely functional protein.

NIU: Why did you choose Lactoferrin as your first bioactive protein, and what science (efficacy and safety) backs or is in the works to back the bioactives?​

LK: Until our technology, Effera (Helaina’s Human Lactoferrin) had not been available in the food or supplement supply. Human Lactoferrin is naturally present throughout the body and is also highly concentrated in human colostrum. Effera is a nutrient like omega-3s or prebiotics, it plays an important role in keeping you healthy.

We are excited about Effera’s potential applications throughout life. Existing clinical studies have evaluated Lactoferrin (bovine and human) in populations from infant through adulthood. Our team has run two clinical studies on Effera and have more planned for the future.  Effera will advance food and supplements in not only the active nutrition category but also women’s health, healthy aging and infant nutrition as well. Effera is well-documented to optimize iron levels, promote healthy gut function and healthy immune function, as well as support a healthy inflammatory response. 

NIU: What are your latest milestones?​

LK: A major milestone for the company this past year was replicating the scientific bench work and creating Effera at commercial scale: 45,000L after three years of R&D.  This marks a critical shift from a R&D company to a commercially viable organization. Similar technologies for ingredients like algae, omega-3s and HMOs took nearly a decade to develop and scale. To date, we have dozens of patents on our technology. Helaina has achieved that in a third of the time without compromising on scientific rigor, efficacy or quality. 

Transparency and high-quality clinical data are of the utmost importance to the team. To support these priorities, our first clinical studies recently concluded and will be published in 2024.

We have successfully manufactured more than 200,000 servings of Effera.

NIU: What is next for Helaina? When will Effera come to market and what is the go-to market strategy? New proteins in development? Long-term goal for the company?​

LK: It is an exciting time for us. Helaina achieved commercial production scale in 2023. Our first clinical study has completed. We are gearing up for a commercial launch with Effera as a branded ingredient soon. Our team has demonstrated early commercial traction. We are already in conversations with major players across our initial target verticals that support Effera’s functional applications. 

Looking to the future, Helaina’s proprietary technology platform can make all types of human bioactive proteins to support health and even customize them for specific use cases. It is a new, sustainable and reliable source of potent nutrients. Future human bioactives from Helaina’s platform will become a new class of nutrients for human health and longevity. 

I see a future where every baby and adult in the world is living a healthier life because they consume our bioactive nutrients. 

NIU: Where do you see the most opportunity in the sports and active nutrition category?​

LK: End-consumers in the performance nutrition category are looking for high-quality, innovative ingredients that are safe, deliver benefits and competitive edge without side effects. For this population and the everyday active person, multifunctionality is increasingly important. Effera delivers on all of the above. 

We are particularly excited about Effera’s potential for sports and active nutrition because of its iron modulating properties. Traditional iron is notoriously hard for the body to absorb and use and yet it is an essential nutrient for energy production and overall healthy physical function. For example, without sufficient Iron, our bodies can't transport oxygen effectively or generate energy.  On the other hand, excess iron is associated with oxidative stress.  Lactoferrin interacts with the immune system to optimize iron use. In fact, Lactoferrin has been clinically studied in athletes with clear benefits. 

NIU: Where do you see the most opportunity for innovation in the industry? What other categories/unmet consumer needs is Helaina exploring?​

LK: Precision fermentation is a widely accepted and well-understood technology. However, in food and supplements it has historically been used to mimic flavors and textures. Instead, we leverage it to promote vitality and healthy living. And in nutrition, there’s been too much focus on calories, vitamins and minerals. We want to broaden how people think about nutrition to include bioactive nutrients inspired by the body’s natural intelligence.

NIU: What Helaina accomplishment are you most proud of to date? ​

LK: Everything we’ve accomplished to date and will accomplish in the future can be attributed to the talented and dedicated team at Helaina. We have an enthusiastic, diverse team of the best and brightest from all backgrounds and walks of life. Our scientists, engineers and business professionals collaborate to achieve what has never been done before—bringing bioactive human proteins to food. Each of them has left a mark on our trajectory, and I couldn’t be more proud.