Finnish biotech firm Onego Bio has received a “no questions” letter from the US Food and Drug Administration, confirming its precision-fermented egg protein, Bioalbumen, as Generally Recognised as Safe (GRAS). The approval allows the ingredient to be used across baked goods, beverages, meat alternatives, confections, sauces, and other applications.
Bioalbumen is produced using a fungal strain, Trichoderma reesei, engineered to generate a protein identical to ovalbumin, the main component of egg whites. The production method requires 95% less land, 97% less water, and generates 89% fewer greenhouse gas emissions than conventional eggs. The resulting powder is a complete protein with a digestibility score of 1.0 and a two-year shelf life.
Onego Bio currently manufactures Bioalbumen at demonstration scale through a European contract facility. The company is developing a flagship plant in Jefferson County, Wisconsin, on a 26-acre site purchased for $777,000. The facility is projected to cost $250–300 million and begin operations in 2028, producing volumes equivalent to six million hens.
The startup has raised $71 million to date, including $55.2 million in Series A funding and an EU grant. It is preparing for a further fundraising round this fall while supplying Bioalbumen samples and trial support to customers ranging from craft bakeries to large-scale food manufacturers.
Separately, Onego Bio has filed a US patent lawsuit against The Every Company and is involved in a related European patent challenge through the VTT Technical Research Centre of Finland, from which it spun off in 2022, to clarify intellectual property rights.