Onego Bio, a Finnish-American food ingredient company, has taken a pivotal step toward innovating the global egg market by submitting a Generally Recognized as Safe (GRAS) notification to the U.S. Food and Drug Administration (FDA) for its animal-free ovalbumin, branded as Bioalbumen®. This protein, produced through precision fermentation using the fungal strain Trichoderma reesei, is bioidentical to the ovalbumin found in chicken eggs, with identical amino acid sequences and comparable nutritional, functional, and performance qualities. If approved, Bioalbumen® could serve as a sustainable, scalable alternative to conventional egg protein, addressing challenges in a global market valued at $300 billion.
Ovalbumin, the dominant protein in egg whites, is a cornerstone ingredient in food production due to its versatility and nutrient profile. Onego Bio’s innovation leverages biotechnology to produce this critical protein without involving chickens. Instead, the process relies on Trichoderma reesei fungi, genetically programmed to produce ovalbumin. These fungi are cultivated in fermentation tanks, where they consume glucose and subsequently secrete proteins. The resulting protein-rich liquid is then refined into a powder form, ready to replace traditional egg protein in products ranging from baked goods and confectionery to ready-made meals and meat alternatives.
Environmental and Supply Chain Benefits
The environmental advantages of Bioalbumen® are striking. Compared to conventional egg production, its manufacturing process requires 95% less land, 97% less water, and generates 89% fewer greenhouse gas emissions. This innovation comes at a crucial time, as the U.S. faces repeated disruptions in the poultry industry due to Avian flu outbreaks, which have destabilized egg prices and highlighted vulnerabilities in the supply chain. By removing chickens from the equation, Bioalbumen® not only mitigates these risks but also contributes to a more resilient and sustainable food system.
Onego Bio’s CEO, Maija Itkonen, underscored the significance of the GRAS submission, calling it a step forward in bolstering food security and sustainability. “By supplementing traditional agricultural inputs, we can help alleviate future supply chain risks and price fluctuations, while delivering benefits to human health, safety, and the environment,” she stated.
The company’s technology aligns with broader trends in food innovation, where alternative proteins are gaining traction. Precision fermentation is emerging as a preferred method for creating bioidentical food ingredients. Companies like The Every Co. are also employing this technique to develop sustainable egg proteins. Meanwhile, plant-based and molecular farming initiatives, such as those by Just and PoLoPo, add further momentum to the sector.
Scaling Up for Market Readiness
The GRAS filing represents a significant step in Bioalbumen®’s journey to market. Once approved, the ingredient could be used across a range of applications, offering a “drop-in” solution for food manufacturers. The company anticipates receiving a “no questions” letter from the FDA in 2025, a milestone that would clear the way for commercialization in the U.S.
To support its ambitions, Onego Bio has recently expanded its infrastructure. The company opened a 5,000-square-foot headquarters in San Diego, California, featuring office space, advanced laboratory facilities, and a test kitchen for demonstrating Bioalbumen®’s capabilities in real-world applications. Additionally, plans are underway to establish a full-scale production facility in the Midwest, with a proposed fermentation capacity of two million liters. This facility could produce a volume of protein equivalent to what six million hens currently supply.
The company’s funding trajectory has also been notable. In July, Onego Bio secured $15.2 million in support from the European Innovation Council Accelerator Program and other investors, bringing its total funding to $70.8 million. These resources are being funneled toward commercializing Bioalbumen® in North America, where the regulatory environment is expected to allow for faster market entry.
Meeting a Growing Demand for Alternatives
Onego Bio’s advancement comes against the backdrop of a growing need for innovative food solutions. Frequent Avian flu outbreaks have heightened concerns about food security and public health, emphasizing the importance of diversifying protein sources. Simultaneously, consumer demand for sustainable and ethical food products is pushing companies to explore alternatives to conventional agriculture.
While traditional eggs remain a staple in diets worldwide, their production is resource-intensive and subject to vulnerabilities. Bioalbumen® presents a viable path forward, offering the same functional properties with a fraction of the environmental impact. The protein’s high digestibility and bioavailability further position it as a nutritionally complete solution for consumers and food manufacturers alike.
As the GRAS notification progresses through regulatory review, Bioalbumen® symbolizes a convergence of scientific innovation and market readiness. Should FDA approval be granted, the protein could help redefine how eggs are sourced, produced, and consumed, with implications that extend far beyond the food industry.
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