Onego Bio secures $15.2m from EIC to scale animal-free egg protein, meet regulatory requirements

The back-to-back capital infusions in a “very, very tough funding environment” are a vote of confidence in Onego Bio’s ability to “solve the massive supply chain issues facing eggs currently globally” stemming from Avian flu and other animal borne diseases, Paavo Salminen, chief business development officer at Onego Bio, told FoodNavigator-USA at IFT FIRST.

He explained that Onego Bio uses precision fermentation to create from fungus the “most functional protein in the egg white,” which the company calls Bioalbumen.

“Fermentation using fungi has been used for thousands and thousands of years, and now have come to a stage where we can use the modern biotechnology to basically harness these fungi … to produce targeted proteins in their bio-identical format – so really how nature has designed them with the amino acids and full nutrition” with a protein digestibility-corrected amino acid score (PDCAAS) score of 1.0 and a whopping 90 grams of protein per 100 grams, he said.

He added that Onego Bio’s dry powdered Bioalbumen ingredient also delivers all the functional benefits of egg whites, including foaming, gelling, binding and texturizing, allowing for its easy use in baked goods, confectioneries, ready-to-eat meals and more.

Funding will ‘skyrocket’ Onego Bio to full commercial scale, regulatory approval​

After perfecting Bioalbumen and entering partnerships with major global food companies to use the ingredient, Onego Bio is moving forward quickly to clear regulatory hurdles and build its own manufacturing unit to meet anticipated high demand.

Both steps are capital intensive, but now within reach thanks to the funding from the European Innovation Council and its Series A fundraise, Salminen said.

“Both of these fundings will skyrocket us to full commercial scale, and we are excited to start the commercial journey in the coming months in the United States as we finalize our regulatory approval process and start supplying our great clientele,” he said.

He explained the highly competitive EIC funding, which was awarded to only 68 out of 969 applicants, will help cover the manufacturing costs and process for receiving regulatory approval from the European Food Safety Authority, which could take upwards of four or five years.

“That is a long period,” and so the company is simultaneously building out its manufacturing capacity in Europe and the US, as well as moving through the much-faster US regulatory process, he said.

He explained that Onego Bio is preparing its application for Generally Recognized As Safe status in the US, for which it anticipates receiving from FDA a letter of no objections in 2025. While filing a GRAS notification with FDA is not required of companies that have self-determined GRAS status, Salminen said Onego Bio is taking this extra step because it is “all about integrity and food safety is our number one priority,” said Salminen.

A letter of no objection from FDA can also help streamline regulatory approval in other countries and reassure potential clients of the ingredient’s safety, he added.

Onego Bio could replace 6 million laying hens as early as 2028​

On track to achieve price parity with animal-based egg protein, which has held back competitors offering animal-free alternatives, Onego Bio is already working with major food companies in the US to feature its ingredient in their products.

Assuming it secures GRAS status as planned in 2025, the company plans to have full scale production up and running by 2028, at which point it will be able to produce 2 million liters of fermentation capacity per full-scale manufacturing unit, which it says is the equivalent of 6 million laying hens.