On Episode #180 of the PricePlow Podcast, Mike and Ben venture into the heart of Manhattan to visit Helaina, where they sit down with Dan DeMarino, Business Development Director, and Anthony Clark, Chief Technology Officer, for an in-depth exploration of precision fermentation technology and effera™ human-equivalent lactoferrin.
Dan DeMarino and Anthony Clark from Helaina dive deep into precision fermentation technology and effera™ human-equivalent lactoferrin, revealing how 5-week development cycles and machine learning models are revolutionizing bioactive protein production on Episode #180 of the PricePlow Podcast.
This conversation provides a fascinating behind-the-scenes look at the science and engineering that makes effera™ possible, from Anthony's revolutionary 5-week development cycles that compress what traditionally took 15 weeks, to the sophisticated machine learning models analyzing 170 million data points. We explore how Helaina has transformed precision fermentation from a months-long process into a predictable engineering paradigm, enabling rapid innovation in bioactive protein development.
The Future is Now: How Precision Fermentation will Change the World
Alongside Anthony's technological prowess, Dan brings his extensive supplement industry experience across several categories to discuss the commercial applications of human lactoferrin. The conversation reveals clinical data showing that effera™ is recognized by the body as "self" with no antibody development, while bovine lactoferrin triggers immune responses.
The biggest question is how to best get the word out there for this phenomenal ingredient. From iron regulation mechanisms to women's health applications, gut health formulations, and the future of human bioactive proteins, this episode showcases why effera™ represents a paradigm shift in nutritional science.
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https://blog.priceplow.com/podcast/helaina-effera-precision-fermentation-180
Video: Helaina's Manhattan Lab with Dan DeMarino & Anthony Clark
Podcast: Play in new window | Download (Duration: 57:07 — 62.8MB)
Detailed Show Notes: Precision Fermentation Meets Supplement Innovation
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0:00 - Introductions: Meeting the Science and Business Leaders
Mike and Ben welcome listeners from Helaina's impressive Manhattan facility, introducing Dan DeMarino, Business Development Director, and Anthony Clark, Chief Technology Officer. Dan brings a decade of supplement industry experience, including seven years at Deerland Probiotics and roles at TSI Group (where PricePlow first encountered him) and American River Nutrition.
Dan describes himself as a product-focused professional with a science background who gets excited by breakthrough technology. His decision to join Helaina stemmed from tracking the company's progress and recognizing an opportunity to work alongside world-class scientists like Anthony in developing revolutionary bioactive proteins.
Anthony's background reveals the caliber of talent Helaina has assembled. The team toured the facility earlier, discovering that virtually every researcher holds a PhD in hard sciences, creating an environment where cutting-edge research can flourish. Dan emphasizes the advantage of being located in Manhattan, where the concentration of global talent enables them to attract brilliant minds from around the world.
The setting provides context for understanding how Helaina has built a predictable R&D organization capable of producing human-identical proteins that were previously impossible to access at scale.
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6:00 - Anthony's Revolutionary R&D Approach: From 15 Weeks to 5 Weeks
Anthony explains how Helaina has transformed precision fermentation from an unpredictable research process into a systematic engineering paradigm. When he arrived at Helaina, traditional strain development cycles took 15 weeks from design to assessment. Through careful workflow mapping and team coordination, they've compressed this timeline to just 5 weeks.
The breakthrough came from analyzing how different teams interconnected and eliminating inefficiencies at transition points. Anthony describes how each team had beautifully organized individual workflows, but the handoffs between teams created bottlenecks and delays. By streamlining these connections and implementing a "design-build-assess" methodology, they achieved unprecedented predictability in biotech development.
This shortened cycle time allows Helaina to test 300 genes every five weeks, dramatically increasing their "shots on target" for optimization. Anthony notes that while they're fortunate to work with yeast rather than plants (which could require 18-month cycles), even compared to other microbial systems, their 5-week timeline represents industry-leading efficiency.
A tour of the R&D facility, where the team is working hard to improve the discovery process, is embedded below:
The systematic approach has attracted attention at industry conferences like the Society of Industrial Microbiology and Biotechnology, where other researchers express amazement at the speed while still working in month-long cycles themselves.
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9:00 - Learning from Experience: Patchouli to Protein in Record Time
Anthony shares his previous experience developing patchouli oil through precision fermentation, which took 14 years to reach commercialization. This lengthy timeline involved taking genes from Indonesian patchouli plants, inserting them into yeast, and scaling the process through partnership with Amyris in the Bay Area.
In contrast, effera™ development achieved scale in just 9 months, progressing from initial protein production to 45,000-liter commercial fermentation capacity. This dramatic improvement demonstrates how Helaina's systematic approach and data-driven methodology can compress development timelines while maintaining quality and efficacy.
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10:30 - Data-Driven Innovation: 170 Million Data Points and Machine Learning
Anthony reveals the sophisticated data infrastructure supporting Helaina's rapid development cycles. Everything is measured and stored in a relational data lake built on Snowflake, containing 170 million lines of data accumulated over three years of operations.
This massive dataset powers 11 machine learning models that enable in silico experiments - theoretical testing that reduces the need for physical bench experiments. Rather than conducting every experiment in the laboratory, the team can use computational models to predict outcomes and optimize approaches before committing resources to physical testing.
The machine-readable data format ensures consistency and enables rapid analysis across multiple variables. This approach allows Helaina to make informed assumptions about experimental outcomes and focus laboratory efforts on the most promising directions, further accelerating their development timelines.
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11:15 - The effera™ Breakthrough: Human Lactoferrin Through Precision Fermentation
Dan explains the significance of what Anthony and the Helaina team have accomplished with effera™, creating lactoferrin that mimics exactly what's found in human breast milk. This represents a major breakthrough that has been desired for human health for decades, with numerous companies investing heavily in trying to achieve what Anthony's team accomplished in just a couple of years.
The importance becomes clear when considering applications like infant nutrition, where making formula healthier for babies represents an obvious benefit. Now, with access to this human-identical molecule, they can extend these benefits into adult nutrition applications.
Helaina's effera™ is revolutionizing supplements with the first human-equivalent lactoferrin. Research shows better bioavailability and reduced immune response compared to bovine sources.
Anthony emphasizes the complexity of the lactoferrin molecule - it's 80 kilodaltons (a very large protein), has 16 disulfide bridges joining it together in specific places, is glycosylated in a particular fashion, has phosphorylation sites, and binds two atoms of iron. If any of these structural elements aren't correct, the protein doesn't function properly.
This complexity explains why it's taken so long for other companies to successfully produce human-identical lactoferrin. Every intervention in the production process must ensure the final protein maintains its exact structural integrity and mimics precisely what's found in human breast milk.
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15:00 - Iron Regulation and Lactoferrin as a Signaling Molecule: Air Traffic Controller Analogy
Dan introduces lactoferrin's primary function as an iron regulator rather than simply an iron supplement, using Anthony's compelling "air traffic controller" analogy to explain the mechanism. In this metaphor, hepcidin acts as the airplane carrying iron cargo (ferritin), while lactoferrin serves as the air traffic controller managing when planes can take off and land.
When inflammation is present (bad weather), lactoferrin prevents iron transport to avoid feeding pathogens that require iron for growth. When conditions are healthy (good weather), lactoferrin facilitates iron movement to tissues that need it. This dynamic regulation explains why lactoferrin can help both iron-deficient and iron-overloaded individuals.
Anthony emphasizes that lactoferrin contains only two atoms of iron per molecule, making it fundamentally different from traditional iron supplements. Rather than delivering large quantities of iron, lactoferrin acts as a signaling molecule that communicates between the liver and other tissues about optimal iron distribution.
The saturation level of lactoferrin in the body serves as an indicator of iron homeostasis health. By functioning as a buffer and communicator, lactoferrin helps manage the complex balance between iron availability and the oxidative stress that excess free iron can create.
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22:00 - Marketing Challenge: Making Iron and Anti-Inflammation Sexy
Dan addresses a critical challenge: iron regulation and anti-inflammatory ingredients aren't inherently exciting to consumers, despite their fundamental importance to health. The team must find ways to communicate complex physiological benefits in terms that resonate with supplement consumers who may be more drawn to immediate, tangible effects.
One approach involves explaining how iron regulates oxygen carrying capacity and how lactoferrin can help increase the amount of oxygen that reaches muscles. This provides a more relatable benefit story, similar to the performance advantages athletes experience from training at altitude. By taking lactoferrin, consumers could theoretically improve their oxygen carrying capacity and perform better.
The team also references lactoferrin's role in colostrum products, which have gained significant market traction. Since lactoferrin is one of the main bioactive components providing colostrum's efficacy, they can leverage this existing consumer understanding and awareness.
Unlike bovine lactoferrin that requires approximately 10,000 liters of cow's milk to produce just 1 kilogram, effera™ utilizes precision fermentation technology to create a human-identical protein. This sustainable manufacturing process ensures consistent quality without the variability or resource intensiveness of animal-sourced ingredients.
However, unlike supplements with immediate sensory feedback (like beta-alanine's tingling sensation), lactoferrin's benefits develop over time through sustained physiological improvements, making consumer education more challenging but ultimately more rewarding for long-term health outcomes.
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23:00 - Strategic Positioning: Women's Health and the "Pink Gold" Opportunity
Mike identifies a compelling strategic direction, noting that the women's health angle represents a massive opportunity for effera™. The iron regulation story is inherently women-centric, as women experience higher rates of anemia due to menstruation and blood loss. The ingredient name "effera" has a somewhat feminine quality, and the ingredient itself appears as a distinctive pink color (what the team calls "pink gold").
Dan enthusiastically agrees, explaining that Helaina has developed a women's platform spanning all phases of life, from prenatal and reproductive years through post-menopause. He believes every woman should consider taking effera™, especially during pregnancy. The applications include table stakes categories like gut health and sports nutrition, with particular emphasis on oxygen carrying capacity benefits.
Research published in Nutrients confirms that effera™ closely mimics human milk lactoferrin's digestion profile, with better survival and similar peptide release patterns than bovine lactoferrin - suggesting superior bioavailability.[1]
The team conducts questionnaires through menses during every clinical study to gather data on how effera™ impacts daily life for women throughout their cycles. This ongoing research provides valuable insights into the powerful effects of effera™ on women's health across different life stages.
This positioning strategy recognizes that lactoferrin levels are estrogen-mediated, meaning production increases during high-estrogen periods and decreases dramatically during perimenopause and menopause, creating significant opportunities for supplementation during these critical transitions.
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25:30 - The Creatine Parallel: Building Effera™ into a Multi-Benefit Category
Dan draws a compelling parallel to creatine's evolution, noting that creatine succeeded by accumulating hundreds of studies across multiple applications - from muscle building to cognitive function to women's health. This represents the pathway effera™ needs to follow, establishing efficacy across pregnant women, sleep quality, muscle development, brain function, and neurodegenerative disease prevention.
The team acknowledges they're at the beginning of this journey, similar to where creatine was in its early days. Dan references his experience at TSI Group with myHMB, which has followed a similar path by continuously studying and building evidence for undeniable health benefits. The key is sustained investment in clinical research across multiple applications.
This strategic approach requires patience and significant investment, but the building blocks are clearly present. The question becomes which companies and brands want to partner with Helaina to build this evidence base and create the story around effera™'s comprehensive health benefits.
The current supplement industry moment provides an ideal environment for this development, with consumers increasingly focused on root cause functional health rather than treating diseases after they develop. The movement toward preventive wellness through lifestyle and targeted compounds creates receptive market conditions for sophisticated ingredients like effera™.
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29:00 - The Prenatal Crisis: 80% of Pregnant Women Are Iron Deficient
Dan reinforces a striking statistic that drives home the importance of effera™ in women's health: over 80% of pregnant women experience iron deficiency. This widespread deficiency leads to serious complications including preterm birth, low birth weight, and developmental issues for both fetus and mother.
We went behind the scenes at Helaina's Manhattan lab to see how they make human-identical effera™ lactoferrin through precision fermentation.
The critical insight is that these women often aren't truly iron deficient in terms of total body stores. Instead, they're experiencing anemia of inflammation, where iron exists in the body but isn't being delivered where it's needed. This occurs when ferritin (iron stores) remains trapped in the liver and other tissues due to inflammatory signaling through hepcidin.
Traditional iron supplements fail to address this underlying issue. Instead of resolving the inflammatory blockage, they often cause gastrointestinal distress (including the telltale black stools that indicate poor absorption) without effectively improving iron utilization. The bioavailability of iron supplements is notoriously low, and the correlation between supplementation and resolution of anemia remains poor.
This harkens back to Anthony's "air traffic controller" analogy, with lactoferrin as a signaling molecule.
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36:00 - Product Showcase: Kepos and the Human Colostrum Concept
Dan presents Kepos, one of the early products featuring effera™, which aims to replicate the benefits of human colostrum using precisely dosed bioactive compounds. While bovine colostrum supplements provide general benefits, Kepos delivers specific amounts of the main bioactive components found in human colostrum, including lactoferrin, HMOs (Human Milk Oligosaccharides), and IgG.
The concept represents "super colostrum" that provides clinically substantiated doses of each bioactive rather than relying on variable concentrations found in bovine colostrum. This approach enables formulators to deliver predictable benefits while avoiding the ethical concerns around taking colostrum from calves.
Dan notes that many early effera™ adopters were already "lactoferrin aficionados" or colostrum enthusiasts who immediately recognized the opportunity to work with human-equivalent proteins. These early partners understood the theoretical advantages and were willing to invest in premium formulations featuring novel ingredients.
What if women's supplements actually addressed iron deficiency AND muscle gains? In Formulator's Corner #18 we designed a hypothetical performance formula centered on effera™ + creatine + HMB -- optimizing iron transport, muscle growth, and recovery without the GI distress.
The product showcases how effera™ can be combined with complementary ingredients like Immunoline (containing 55 clinical studies supporting its IgG content) to create comprehensive immune and gut health formulations that exceed what bovine colostrum alone can provide.
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41:30 - Formulating the Perfect Gut Health Supplement
Upon Mike's request, Dan spontaneously formulates his ideal gut health supplement, demonstrating the practical application of his decade of industry experience. His comprehensive approach follows the "seed, feed, weed" methodology for optimal microbiome support, incorporating multiple mechanisms of action.
- For the seed component (probiotics), Dan recommends DE-111 (a spore-forming probiotic he trusts), along with highly studied strains like Rhamnosus GG and Lactobacillus and Bifidobacterium species. This combination targets different areas of the gut with various anaerobic and facultative anaerobic organisms.
- The feed component includes PreforPro (bacteriophages that selectively eliminate pathogenic bacteria) and soluble fiber to nourish beneficial bacteria. Dan particularly emphasizes PreforPro's ability to rapidly impact microbiome ecology with predictable results every time.
- For the weed component, both PreforPro and effera™ help eliminate harmful bacteria while promoting beneficial species. Dan adds butyrate supplementation to support gut lining health and nutrient absorption, despite acknowledging the formulation challenges due to butyrate's unpleasant odor (comparing it to stomach acid).
The resulting formulation addresses microbiome seeding, beneficial bacteria promotion, pathogen elimination, and gut lining integrity - a comprehensive approach to gut health that effera™ enhances through its anti-inflammatory and iron-regulating properties.
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47:00 - Clinical Research Pipeline: Three Studies Define the Future
Dan outlines Helaina's ambitious clinical research program, focusing on three major studies designed to establish effera™'s efficacy in gut health applications. The company is conducting a microbiome study at the University of Illinois with detailed analysis of bacterial composition changes following effera™ supplementation.
Laura Katz, founder and CEO of Helaina, discusses the revolutionary effera™ human-identical lactoferrin technology and precision fermentation platform on Episode #167 of the PricePlow Podcast.
A large-scale gut permeability study examines effera™'s effects on tight junction proteins and epithelial lining integrity. Dan describes this as a "landmark clinical" that's expensive and complicated but represents critical research for understanding how effera™ supports gut barrier function.
The third study involves IBD/IBS patients and focuses on butyrate-producing bacteria proliferation with effera™ supplementation. This research targets the "gut trifecta" of microbiome balance, barrier integrity, and anti-inflammatory effects.
Beyond gut health, Helaina's clinical roadmap includes 50+ planned studies covering sports nutrition applications, creatine synergies, strength and performance outcomes, women's health, and prenatal applications. Dan emphasizes that while prenatal studies are expensive and challenging, they represent a critical area for clinical validation.
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49:00 - Clinical Validation: No Immune Response to Human Protein
Anthony shares results from Helaina's landmark immunogenicity study, which directly compared effera™ with bovine lactoferrin over an 84-day period.[2] The study's most significant finding was that participants taking bovine lactoferrin developed antibodies against the protein,[2] indicating their immune systems were actively trying to clear it as a foreign substance.
In contrast, participants taking effera™ showed no antibody development at any dose level,[2] proving the body recognizes human-identical lactoferrin as "self." This finding validates the theoretical advantages of human-equivalent proteins and has profound implications for supplement efficacy.
The study included comprehensive safety assessments with fecal samples, sputum analysis, and other biomarkers analyzed by Sharon Donovan's lab at the University of Illinois. Preliminary results show "directionally very interesting changes in the microbiome" that support effera™'s gut health benefits.
A separate small cohort study in IBS patients demonstrated reduced Clostridia populations, which Anthony describes as a necessary prerequisite for microbiome improvement. These clinical results provide strong evidence for effera™'s superior biocompatibility and efficacy compared to bovine alternatives.
There's so much more to come, and we couldn't be more excited about the future after visiting Helaina's R&D lab.
Where to Follow Helaina and the Team
- Dan DeMarino: LinkedIn
- Anthony Clark: LinkedIn
- Helaina:
- Company Website (LinkedIn)
- Learn about effera™ on PricePlow
- Inside Helaina's Manhattan Lab: A Deep Dive into Precision Fermentation and Human-Identical Lactoferrin
- Helaina news on PricePlow
- Previous Episode:
Thank you to Dan and Anthony for providing an insider's look at the science and engineering behind effera™ and sharing their expertise in both precision fermentation technology and supplement industry applications. This conversation demonstrates how breakthrough biotechnology combined with deep industry knowledge can create ingredients that fundamentally advance human nutrition.
From Anthony's revolutionary development cycles to Dan's practical formulation insights, Helaina is positioned to lead the transformation from animal-derived to human-identical bioactive proteins. The clinical evidence supporting effera™'s superior biocompatibility, combined with the scalable manufacturing platform, suggests we're witnessing the early stages of a major shift in how we approach nutritional supplementation.
Subscribe to the PricePlow Podcast for more conversations with the scientists and entrepreneurs reshaping the supplement industry through innovation and evidence-based development -- we have another episode from this trip coming that includes Laura and Pam!
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