Onego Bio Files GRAS Notice to FDA to Sell Animal-Free Egg Protein in US

Finnish food tech startup Onego Bio has submitted a formal notice to the FDA, asserting the safety of Bioalbumen, its precision-fermented egg protein.

Onego Bio is targeting the US as the first market for its recombinant egg protein, having notified the Food and Drug Administration (FDA) about the safety of its Bioalbumen ingredient.

The animal-free version of ovalbumin – which makes up 54% of the protein content in egg whites – is made from precision fermentation, which combines traditional fermentation processes with the latest advancements in biotechnology to produce a target compound (egg protein, in this case).

Just days ago, the company signed a letter of intent to purchase a 25.9-acre piece of land in Jefferson, Wisconsin. With an initial spend of $777,000, the agreement provides a 12-month due diligence period with two consecutive extensions of up to six months.

It comes months after Onego Bio – which currently works with co-manufacturers – received a $2M grant through the Department of Defense’s Distributed Bioindustrial Manufacturing Program, specifically to plan a facility to produce Bioalbumen in the Midwest.

“Our GRAS filing marks a significant milestone for Onego Bio, reinforcing our commitment to building a more resilient supply chain and sustainable food system,” said co-founder and CEO Maija Itkonen.

“By supplementing traditional agricultural inputs, we can help alleviate future supply chain risks and price fluctuations and provide significant benefits to human health and safety and the environment.”

How Onego Bio makes its egg protein

Onego Bio uses a fungal strain called Trichoderma reesei to create a bioidentical version of ovalbumin, but without the chickens. It introduces the genetic blueprint of ovalbumin to the fungi cells through a scientific database that acts like a library, enabling them to produce egg proteins instead of their own.

The microbes are fed on sugar and – depending on the stage of the production process – are either starved with little food or allowed to “gorge on glucose”. This is because once they consume plenty of glucose and are then starved of it, they start sweating proteins.

The resulting Bioalbumin is then placed into a fermentation tank with water and fungal biomass. The latter is separated to procure a liquid containing the egg protein, which is then dried into a powder.

Described as a nutritionally complete protein, Bioalbumen has an identical amino acid sequence to its chicken-derived counterpart, and boasts the highest possible protein digestibility score (90g per 100g of egg white).

Meanwhile, producing the protein requires 95% less land and 97% less water compared to conventional eggs, while generating 89% fewer greenhouse gas emissions.

Crucially, it protects against the rising threat of Avian flu on both public health and the egg supply chain, with frequent outbreaks amplifying the volatility of egg prices over the last few years. The startup has said that its “highly productive and scalable” tech will enable it to offer competitive pricing to chicken eggs.

Bioalbumen can be used in a variety of applications

The GRAS notification is an important step in Onego Bio’s path to market, demonstrating that the recombinant protein complies with the FDA’s safety standards for its intended uses, which range from baked goods, snacks and confectionery to sauces, pasta, meat alternatives, and ready meals. The company has previously indicated that it expects to receive a ‘no questions’ letter from the agency in 2025.

After the purchase agreement of the Wisconsin facility (which is non-binding), a company spokesperson told BizTimes: “Onego Bio’s purpose is to advance sustainable solutions for the future of food. As we continue our mission to serve the world the perfect protein, we are focused on building world-class infrastructure that creates unmatched value for our customers and the marketplace.”

They added: “We are excited at the potential of expanding our footprint into the Midwest as the region offers logistical advantages, is close to our customer base, and provides direct access to the critical feedstock that supports our biomanufacturing.”

The startup has previously indicated that a single full-scale manufacturing unit will boast a fermentation capacity of two million litres, which can produce protein equivalent to what’s produced by six million hens.

Onego Bio recently secured $15.2M in a funding round, which itself followed a $40M Series A investment, taking its total raised past $70M. And it also has plans to submit dossiers for novel food approval in the EU, South America, and Asia.

While plant-based versions like Just Egg and Yo Egg are more commonplace, only a handful of companies are innovating with eggs through precision fermentation. California’s The Every Co has received three ‘no questions’ letters from the FDA and partnered with a host of brands for applications ranging from beverage mixes to meat analogues. And Germany’s Formo is set to launch a precision-fermented egg alternative, though that isn’t bioidentical.