Finnish startup Onego Bio has secured a ‘no questions’ letter from the US FDA, strengthening the regulatory status of its precision-fermented egg protein.
As the US mulls changes to how new foods are regulated, some companies are getting ahead of the policy overhaul.
Finland’s Onego Bio, which makes recombinant egg proteins using precision fermentation, has received a ‘no questions’ letter from the Food and Drug Administration (FDA). The regulatory body has concluded that the startup’s Bioalbumen ingredient is Generally Recognized as Safe (GRAS) for use in a wide variety of applications.
It comes nine months after the firm first filed its GRAS notice to the FDA, and six months after it purchased land in Wisconsin to build a large-scale facility capable of producing the same amount of egg protein as six million hens.
“The FDA’s conclusions now confirm our right to commercialise and give customers full confidence in incorporating Bioalbumen as a reliable food solution,” says co-founder and CEO Maija Itkonen.
The regulator has moved to potentially eliminate the self-affirmed GRAS rule next year, which would force companies to submit notices for FDA review and potentially delay companies’ ability to bring new ingredients to market.
And while the change would not affect ingredients that are already determined as GRAS, many producers would choose to pursue the FDA letter anyway to increase confidence among clients and customers.
“Integrity and transparency are at the heart of everything we do – our business, our technology, our intellectual property, and our collaboration with customers and partners,” says Itkonen. “That’s why we pursued the full FDA GRAS review process.”
How Onego Bio makes its chicken-free egg protein
A spinout of the VTT Technical Research Centre of Finland, Onego Bio uses a fungal strain called Trichoderma reesei to produce a bioidentical version of ovalbumin, which makes up 54% of the protein found in egg whites.
Its precision fermentation process involves introducing the genetic blueprint of ovalbumin to the cells of the microorganisms, which are fed on sugar. Depending on the stage of the production process, they’re either starved with little food or allowed to “gorge on glucose” – once they consume plenty of glucose and are then starved of it, they start sweating proteins.
These proteins are then filtered out and dried into a powder. The process requires 95% less land and 97% less water compared to conventional eggs, while generating 89% fewer greenhouse gas emissions.
Onego Bio’s Bioalbumen is a complete protein with an amino acid sequence identical to ovalbumin and a protein digestibility score of 1.0 (the highest possible score). It has a two-year-long shelf life and can replace egg white protein powder or liquid egg alternatives in most applications.
The FDA letter confirms that the chicken-free egg white protein can function as a foaming, gelling, and binding agent in baked goods, beverages, meat analogues, confections, sauces, and more.
“We currently manufacture [on a] demo scale through a contract manufacturer in Europe, planning for larger volumes, and are progressing plans to build a flagship production facility in Jefferson County, Wisconsin,” Itkonen tells Green Queen.
The plant will be located at the Food and Beverage Innovation Campus, built on a 26-acre piece of land Onego Bio bought for $777,000. The startup is expected to spend $250-300M to build the new facility, which is set to begin operations in 2028.
Onego Bio gears up for fundraise amid US lawsuit
Through its future-friendly protein, Onego Bio is tackling the egg crisis that has left the US food industry in a bind. The avian flu crisis pushed egg prices to record highs this year – in some cities, chicken eggs cost $1 a pop.
Manufacturers have been looking for alternative solutions. Eat Just, maker of the mung-bean-derived Just Egg, saw sales of its vegan substitutes grow five times faster in January than in the past year, with 56% of shoppers returning to buy more (a three-point increase from 2024).
But plant-based egg replacers can only go so far. Precision fermentation offers companies like-for-like functionality that can seamlessly bed into their processes. “Our priority is giving food manufacturers a dependable source of high-quality egg protein so they can count on consistent availability and stable, competitive pricing,” says Itkonen.
“We’re continuing to supply Bioalbumen samples and trial support to a range of customers, from craft bakeries to large-scale food manufacturers. Collaborations cover everything from baked goods, sauces, confections, savoury products, and more,” she adds.
The startup has raised nearly $71M to date, which includes $55.2M from Series A investors and an EU grant in 2024. Now, it’s gearing up for more. “We are excited to kick off our next fundraising round this fall,” Itkonen reveals.
And earlier this month, it sued California’s The Every Company, a fellow precision-fermented egg protein startup, to invalidate a key patent granted to the latter in the US, accusing it of fraud. Shortly after, the VTT Technical Research Centre of Finland (which Onego Bio spun off from) challenged one of Every’s patents in Europe.
Itkonen says the two cases are not related. Asked to comment on its lawsuit in the US, she notes: “We filed this action to protect our ownership and to bring clarity around a recently issued patent that we believe is invalid.
“Our intention is not to block progress but to safeguard it. We have deep respect for legitimate intellectual property and value fair competition, which we see as the foundation of a healthy market.”
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