Agronomics Limited Announces Onego Bio Update
Onego Bio, a portfolio company of Agronomics (AGNMF), has achieved a significant regulatory milestone as the FDA issued a "no questions" letter regarding the GRAS status of its Bioalbumen® product. This egg protein alternative, produced through precision fermentation, can now be used as a dietary protein source and functional ingredient in various food applications.
The company plans to construct its flagship production facility in Jefferson County, Wisconsin, to scale manufacturing. Agronomics has invested £7.1 million in Onego Bio, with the position currently valued at £11.2 million, representing approximately 7.5% of Agronomics' Net Asset Value as of June 30, 2025.
Onego Bio, una società del portafoglio di Agronomics (AGNMF), ha raggiunto una significativa tappa normativa: la FDA ha emesso una lettera di «no questions» riguardo allo status GRAS del suo prodotto Bioalbumen®. Questo sostituto proteico delle uova, prodotto mediante fermentazione di precisione, può ora essere utilizzato come fonte proteica alimentare e come ingrediente funzionale in diverse applicazioni alimentari.
L’azienda intende costruire il suo impianto di produzione di punta a Jefferson County, Wisconsin, per aumentare la scala della produzione. Agronomics ha investito £7,1 milioni in Onego Bio, con la posizione attualmente valutata a £11,2 milioni, rappresentando circa il 7,5% del Net Asset Value di Agronomics al 30 giugno 2025.
Onego Bio, una empresa de cartera de Agronomics (AGNMF), ha logrado un hito regulatorio significativo: la FDA ha emitido una carta de «no questions» respecto al estatus GRAS de su producto Bioalbumen®. Este sustituto de proteína de huevo, producido mediante fermentación de precisión, ya puede usarse como fuente de proteína en la dieta y como ingrediente funcional en diversas aplicaciones alimentarias.
La compañía planea construir su planta de producción insignia en Jefferson County, Wisconsin, para escalar la fabricación. Agronomics ha invertido £7,1 millones en Onego Bio, y la posición está actualmente valorada en £11,2 millones, representando aproximadamente el 7,5% del Net Asset Value de Agronomics al 30 de junio de 2025.
Onego Bio, Agronomics (AGNMF)의 포트폴리오 기업은 FDA가 Bioalbumen®의 GRAS 상태에 대해 'no questions'라는 서한을 발행하는 등 중요한 규제 이정표를 달성했습니다. 정밀 발효를 통해 생산되는 이 달걀 단백질 대체품은 이제 다양한 식품 적용에서 식이 단백질 공급원 및 기능성 성분으로 사용할 수 있습니다.
회사는 제조 규모 확장을 위해 위스콘신주 제퍼슨 카운티에 있어 시그니처 생산시설을 건설할 계획입니다. Agronomics는 Onego Bio에 £7.1백만을 투자했으며, 현재 지분 가치는 £11.2백만으로 평가되며 이는 2025년 6월 30일 기준 Agronomics의 순자산가치의 약 7.5%에 해당합니다.
Onego Bio, une société du portefeuille de Agronomics (AGNMF), a franchi une étape réglementaire majeure lorsque la FDA a délivré une lettre « no questions » concernant le statut GRAS de son produit Bioalbumen®. Cet équivalent des protéines d’œuf, produit par fermentation de précision, peut désormais être utilisé comme source de protéines alimentaires et comme ingrédient fonctionnel dans diverses applications alimentaires.
L’entreprise prévoit de construire son usine de production phare à Jefferson County, Wisconsin afin de d’échelonner la fabrication. Agronomics a investi £7,1 millions dans Onego Bio, et la position est actuellement évaluée à £11,2 millions, soit environ 7,5% de la valeur d’actif net de Agronomics au 30 juin 2025.
Onego Bio, ein Portfolio-Unternehmen von Agronomics (AGNMF), hat einen bedeutenden regulatorischen Meilenstein erreicht, da die FDA ein «no questions»-Schreiben betreffend den GRAS-Status seines Produkts Bioalbumen® ausgestellt hat. Dieser Ei-Protein-Ersatz, hergestellt durch Präzisionsfermentation, kann nun als diätetische Proteinquelle und als funktionales Zutaten in verschiedenen Lebensmittelsanwendungen verwendet werden.
Das Unternehmen plant den Bau seiner Flagship-Produktionsanlage in Jefferson County, Wisconsin, um die Fertigungskapazität zu skalieren. Agronomics hat £7,1 Millionen in Onego Bio investiert, die Position wird derzeit mit £11,2 Millionen bewertet, was ca. 7,5% des Net Asset Value von Agronomics zum Stichtag 30. Juni 2025 entspricht.
Onego Bio، إحدى شركات محفظة Agronomics (AGNMF)، حققت خطوة تنظيمية كبيرة بعدما أصدرت إدارة الغذاء والدواء الأمريكية خطاباً بلا أسئلة فيما يخص وضع GRAS لمنتجها Bioalbumen®. هذا البديل لبروتين البيض، المُنتَج عبر التخمر الدقيق، يمكن الآن استخدامه كمصدر بروتين غذائي وكمكوّن وظيفي في تطبيقات غذائية متنوعة.
تخطط الشركة لبناء منشأة الإنتاج الرئيسية في Jefferson County, Wisconsin لتوسيع التصنيع. استثمرت Agronomics مبلغ 7.1 مليون جنيه إسترليني في Onego Bio، وتُقيَّمPosition حاليًا بـ 11.2 مليون جنيه إسترليني، ما يمثل حوالي 7.5% من قيمة الأصول الصافية لـ Agronomics حتى تاريخ 30 يونيو 2025.
Onego Bio，是 Agronomics (AGNMF) 的投资组合公司，在监管方面取得重大里程碑，因为FDA 就其 Bioalbumen® 的 GRAS 状态发出“no questions”信函。这一通过精准发酵生产的鸡蛋蛋白替代品现在可用作膳食蛋白来源和多种食品应用的功能性成分。
公司计划在 威斯康星州杰斐逊县建设旗艦级生产设施，以扩展制造规模。Agronomics 已向 Onego Bio 投资 710 万英镑，其当前估值为 1120 万英镑，约占 Agronomics 截至 2025 年 6 月 30 日净资产价值的 7.5%。
- FDA GRAS status approval enables broad commercial use of Bioalbumen® in food applications
- Product offers solution to supply chain disruptions caused by avian flu and extreme weather
- Planned Wisconsin facility will ensure scalable manufacturing capacity
- Investment value has appreciated from £7.1M to £11.2M for Agronomics
- Manufacturing facility not yet operational, pending construction
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
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
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
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FAQ
What is the significance of FDA's 'no questions' letter for Onego Bio's Bioalbumen®?
How does Bioalbumen® compare to traditional egg protein?
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