{"id":61901,"date":"2025-09-22T16:04:09","date_gmt":"2025-09-22T14:04:09","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/onego-bio-receives-fda-no-questions-letter-on-gras-status-of-bioalbumen\/"},"modified":"2025-09-22T16:04:09","modified_gmt":"2025-09-22T14:04:09","slug":"onego-bio-receives-fda-no-questions-letter-on-gras-status-of-bioalbumen","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/onego-bio-receives-fda-no-questions-letter-on-gras-status-of-bioalbumen\/","title":{"rendered":"Onego Bio Receives FDA \u201cNo Questions\u201d Letter on GRAS Status of Bioalbumen\u00ae"},"content":{"rendered":"
\n

SAN DIEGO–(BUSINESS WIRE)–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 \u201cno questions\u201d letter regarding the company\u2019s conclusion that its flagship product, marketed as Bioalbumen\u00ae, is Generally Recognized As Safe (GRAS) under its conditions of use in a wide range of food and beverage applications.<\/p>\n

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\nThe FDA\u2019s decision, communicated in response to GRAS Notice No. GRN 1249, confirms that Bioalbumen\u00ae\u2014a highly functional ovalbumin protein with an amino acid sequence identical to that found in chicken eggs\u2014can 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.<\/p>\n

\nProduced via precision fermentation with the filamentous fungus Trichoderma reesei<\/i>, Bioalbumen\u00ae delivers high-quality nutrition and matches the functionality of traditional egg protein. It is designed to diversify egg protein sources for food manufacturers\u2014which represents a third of all eggs produced for industrial use\u2014providing 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.<\/p>\n

\n\u201cThis GRAS \u2018no questions\u2019 letter from the FDA is an important milestone for Onego Bio and the culmination of long-term scientific research,\u201d said Maija Itkonen, CEO and Co-Founder of Onego Bio. \u201cBioalbumen\u00ae 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.\u201d<\/p>\n

\nThese conclusions from the FDA follows Onego Bio\u2019s recent announcement<\/a> of plans to construct its flagship production facility in Jefferson County, Wisconsin, where the company will scale Bioalbumen\u00ae manufacturing to meet sustained high demand, ensuring uninterrupted supply at every level. This milestone increases Onego\u2019s 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.<\/p>\n

\n\u201cAt Onego, integrity and transparency are at the heart of everything we do\u2014our business, our technology, our intellectual property, and our collaboration with customers and partners,\u201d added Itkonen. \u201cThat\u2019s why we pursued the full FDA GRAS review process. Based on that commitment, the FDA\u2019s conclusions now confirm our right to commercialize and gives customers full confidence in incorporating Bioalbumen \u00ae as a reliable food solution.\u201d<\/p>\n

\nAbout Onego Bio<\/p>\n

\nOnego Bio is a food ingredient company on a mission to create a more resilient food system through its product Bioalbumen\u00ae<\/sup>\u2014the first non-animal egg protein with an amino acid sequence identical to the natural protein. Made through precision fermentation, Bioalbumen\u00ae<\/sup> 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<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Contacts:
\n
press@onego.bio<\/a><\/p>\n

General Inquiries:
\n
hello@onego.bio<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

SAN DIEGO–(BUSINESS WIRE)–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 \u201cno questions\u201d letter regarding the company\u2019s conclusion that its flagship product, marketed as Bioalbumen\u00ae, is Generally Recognized As Safe (GRAS) under its conditions of use in a wide … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61901","6":"format-standard","7":"category-industry"},"yoast_head":"\nOnego Bio Receives FDA \u201cNo Questions\u201d Letter on GRAS Status of Bioalbumen\u00ae - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/onego-bio-receives-fda-no-questions-letter-on-gras-status-of-bioalbumen\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Onego Bio Receives FDA \u201cNo Questions\u201d Letter on GRAS Status of Bioalbumen\u00ae - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SAN DIEGO–(BUSINESS WIRE)–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 \u201cno questions\u201d letter regarding the company\u2019s conclusion that its flagship product, marketed as Bioalbumen\u00ae, is Generally Recognized As Safe (GRAS) under its conditions of use in a wide ... 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