Onego Bio seeks FDA approval for non-animal egg protein Bioalbumen

Onego Bio, a Finnish-US food ingredient company, has submitted a Generally Recognized as Safe (GRAS) notification to the US Food and Drug Administration (FDA) for its innovative product, Bioalbumen.

Bioalbumen is a non-animal ovalbumin—the primary protein in egg whites—produced through precision fermentation using the microorganism Trichoderma reesei. This process yields a protein with an amino acid sequence identical to that of natural ovalbumin, offering a sustainable alternative to conventional egg production.

Maija Itkonen, CEO of Onego Bio, emphasized the significance of this development. "Our GRAS filing marks a significant milestone for Onego Bio, reinforcing our commitment to building a more resilient supply chain and sustainable food system." She added that supplementing traditional agricultural inputs with Bioalbumen can help alleviate future supply chain risks and price fluctuations, providing significant benefits to human health, safety, and the environment.

The GRAS notification is a critical step in demonstrating that Bioalbumen meets the FDA's safety standards for its intended uses. Designed as a drop-in solution, Bioalbumen can be utilized across a wide range of applications where eggs are traditionally used, including baked goods, confectionery, pasta, and ready-made meals.

Onego Bio highlights several environmental advantages of Bioalbumen over conventional egg production, including reductions of 89% in greenhouse gas emissions, 95% in land use, and 87% in water consumption. Additionally, producing egg protein through fermentation mitigates risks associated with avian influenza, thereby enhancing food security and public health.

This submission follows Onego Bio's recent expansion into the US market, including the opening of a commercial headquarters in San Diego, California. The company has also secured significant funding to advance its mission of creating a more resilient food system through innovative, sustainable food ingredients.

By leveraging precision fermentation technology, Onego Bio aims to revolutionize the global egg market, addressing supply chain challenges and contributing to a more sustainable and secure food future.