NEW TECH FOODS

The US Food and Drug Administration (FDA) has issued a “no questions” letter to Onego Bio, confirming that its precision-fermented egg protein Bioalbumen is Generally Recognized as Safe (GRAS) for use in a variety of food and beverage applications.

The decision affirms that Bioalbumen – a functional ovalbumin protein with the same amino acid sequence as chicken-derived egg protein – can be used as a dietary protein source and as a foaming, gelling and binding agent in products including baked goods, beverages, meat alternatives, confections and sauces.

Bioalbumen is produced using the filamentous fungus Trichoderma reesei through precision fermentation.

Onego Bio said the ingredient offers nutritional and functional parity with conventional egg protein, while providing food manufacturers with an alternative supply chain that could reduce exposure to market volatility and Avian Influenza-related disruptions.

Maija Itkonen, CEO and co-founder of Onego Bio, said: “This GRAS ‘no questions’ letter from the FDA is an important milestone for Onego Bio and the culmination of long-term scientific research".

"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.”

The regulatory clearance follows Onego Bio’s announcement of plans to build a production facility in Jefferson County, Wisconsin. The site will scale up Bioalbumen manufacturing to meet demand and anchor the company’s US operations.

Itkonen added: “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. That’s why we pursued the full FDA GRAS review process."

"Based on that commitment, the FDA’s conclusions now confirm our right to commercialise and gives customers full confidence in incorporating Bioalbumen as a reliable food solution.”