Onego Bio Receives FDA "No Questions" Letter on GRAS Status of Bioalbumen(R)
DOUGLAS, ISLE OF MAN / ACCESS Newswire / September 23, 2025 / Onego Bio Limited ("Onego Bio"), a food ingredient company producing egg protein through precision fermentation, announced today that the U.S. Food and Drug Administration ("FDA") has issued a "no questions" letter regarding the company's conclusion that its flagship product, marketed as Bioalbumen®, is Generally Recognized As Safe ("GRAS") under its conditions of use in a wide range of food and beverage applications.
The FDA's decision, communicated in response to GRAS Notice No. GRN 1249, confirms that Bioalbumen®-a highly functional ovalbumin protein with an amino acid sequence identical to that found in chicken eggs-can be used as a source of dietary protein and, for example, as a foaming, gelling, and binding agent in baked goods, beverages, meat analogs, confections, sauces, and more.
These conclusions from the FDA follows Onego Bio's recent announcement of plans to construct its flagship production facility in Jefferson County, Wisconsin, where the company will scale Bioalbumen® manufacturing to meet sustained high demand, ensuring uninterrupted supply at every level. This milestone increases Onego's confidence in anchoring the facility for their U.S. operations and supports its partnerships with leading food and beverage companies seeking more secure and sustainable commodity ingredients.
Speaking about the announcement, Jim Mellon, Executive Chairman of Agronomics said: "This milestone signals the beginning of what can be a hugely significant industry in the USA. Achieving GRAS status can drive job creation and economic growth at Onego Bio's facility in Wisconsin, as well as answer the need from manufacturers for an ingredient which is not only sustainable, but which can bolster supply chain security too.
The production of clean 'core' ingredients like Bioalbumin®, which have the same benefits and functionality as the ingredients they replace, is becoming increasingly more important as threats to supply chains, such as avian flu and extreme weather, mount. We look forward to continuing our support for clean food technologies such as Onego Bio, as these solutions show what a positive, secure and sustainable food system looks like."
To date, Agronomics has invested a total of £7.1 million in Onego Bio which, subject to audit, is currently carried at £11.2 million. This position represents c.7.5% of Agronomics' last stated Net Asset Value as at 30th of June 2025.
The full announcement is set out below without any material changes:
Onego Bio Receives FDA "No Questions" Letter on GRAS Status of Bioalbumen®
San Diego, USA- September 22, 2025 - Onego Bio, a food ingredient company producing egg protein through precision fermentation, announced today that the U.S. Food and Drug Administration (FDA) has issued a "no questions" letter regarding the company's conclusion that its flagship product, marketed as Bioalbumen®, is Generally Recognized As Safe (GRAS) under its conditions of use in a wide range of food and beverage applications.
The FDA's decision, communicated in response to GRAS Notice No. GRN 1249, confirms that Bioalbumen®-a highly functional ovalbumin protein with an amino acid sequence identical to that found in chicken eggs-can be used as a source of dietary protein and, for example, as a foaming, gelling, and binding agent in baked goods, beverages, meat analogs, confections, sauces, and more.
Produced via precision fermentation with the filamentous fungus Trichoderma reesei, Bioalbumen® delivers high-quality nutrition and matches the functionality of traditional egg protein. It is designed to diversify egg protein sources for food manufacturers, which represents a third of all eggs produced for industrial use, providing a secure supply while reducing price volatility and production disruptions. Additionally, supplementing the industrial egg supply offers a strong defense against the increasing threat of Avian Influenza on food security and public health across the U.S.
"This GRAS "no questions" letter from the FDA is an important milestone for Onego Bio and the culmination of long-term scientific research." said Maija Itkonen, CEO and Co-Founder of Onego Bio. "Bioalbumen® provides the same high-quality nutrition and performance as conventional egg protein. Our U.S. commercial and R&D team continues to sample and provide trial support to an array of food customers ranging from craft bakeries to large scale food manufacturers."
These conclusions from the FDA follows Onego Bio's recent announcement of plans to construct its flagship production facility in Jefferson County, Wisconsin, where the company will scale Bioalbumen® manufacturing to meet sustained high demand, ensuring uninterrupted supply at every level. This milestone increases Onego's confidence in anchoring the facility for their U.S. operations and supports its partnerships with leading food and beverage companies seeking more secure and sustainable commodity ingredients.
"At Onego, 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," added Itkonen. "That's why we pursued the full FDA GRAS review process. Based on that commitment, the FDA's conclusions now confirm our right to commercialize and gives customers full confidence in incorporating Bioalbumen ® as a reliable food solution."
About Onego Bio
Onego Bio is a food ingredient company on a mission to create a more resilient food system through its product Bioalbumen®-the first non-animal egg protein with an amino acid sequence identical to the natural protein. Made through precision fermentation, Bioalbumen® matches the taste, nutrition, and functionality of the main protein from traditional eggs with an environmental impact around 90% smaller. Its unmatched versatility makes it ideal across a wide range of applications, while providing greater cost and supply stability for food manufacturers. Learn more at www.onego.bio.
About Agronomics
Agronomics is a leading London-listed company focusing on investment opportunities within the field of clean food. The Company has established a portfolio of over 20 companies in this rapidly advancing sector. It seeks to invest in companies owning technologies with defensible intellectual property that offer new ways of producing food and materials with a focus on products historically derived from animals.
These technologies are driving a major disruption in agriculture, offering solutions to improve sustainability, as well as addressing human health, animal welfare and environmental damage. This disruption will decouple supply chains from the environment and animals and improve food security for the world's expanding population. A full list of Agronomics' portfolio companies is available at https://agronomics.im/.
For further information, please contact:
Agronomics Limited | Beaumont Cornish Limited | Canaccord Genuity Limited | Cavendish Capital Markets Limited | Peterhouse Capital Limited | 33Seconds Limited |
The Company | Nomad | Joint Broker | Joint Broker | Joint Broker | Public Relations |
Jim Mellon Denham Eke | Roland Cornish James Biddle | Andrew Potts Harry Pardoe | Giles Balleny Michael Johnson | Lucy Williams Charles Goodfellow | Jack Ferris Calum Warren-Piper |
+44 (0) 1624 639396 info@agronomics.im | +44 (0) 207 628 3396 | +44 (0) 207 523 8000 | +44 (0) 207 397 8900 | +44 (0) 207 469 0936 | agronomics@33seconds.co |
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SOURCE: Agronomics Limited
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/agriculture/agronomics-limited-announces-onego-bio-update-1077144
