Food ingredient company Onego Bio has received a “No Questions” letter from the US Food and Drug Administration (FDA) regarding Bioalbumen®, its egg protein produced through precision fermentation.
The letter supports Onego Bio’s conclusion that Bioalbumen is Generally Recognized As Safe (GRAS) under its conditions of use in a wide range of food and beverage applications. This decision confirms that the ingredient can be used as a source of dietary protein or a foaming, gelling, and binding agent in a variety of products, including baked goods, beverages, meat analogs, confections, sauces, and more.
Bioalbumen is described as a highly functional ovalbumin protein with an amino acid sequence identical to that found in chicken eggs. It is produced via precision fermentation using the filamentous fungus Trichoderma reesei.
“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 US 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.”
“Reliable food solution”
Bioalbumen is designed to diversify egg protein sources for food manufacturers, providing a secure supply while reducing price volatility and production disruptions. This could help to mitigate the threat posed by avian influenza to food security and public health.
The issuing of the No Questions letter comes after Onego Bio announced plans to construct a flagship production facility in Jefferson County, Wisconsin, earlier this year. This will allow the company to scale the manufacturing of Bioalbumen to meet sustained high demand.
“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,” said 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 give customers full confidence in incorporating Bioalbumen® as a reliable food solution.”
