Imagindairy's self-affirmed GRAS for animal-free dairy protein paves way for commercial partnerships in the US

After “significant internal and external review and safety testing,” the company announced this week that it notified FDA that it self-affirmed as Generally Recognized As Safe its animal-free whey protein.

“Securing self-affirmed GRAS status is a pivotal step in the commercialization of Imagindairy’s animal-free dairy protein. GRAS status signifies that the ingredient is safe to be used in food and beverage products, providing a regulatory ‘green light’ for food and beverage manufacturers to partner with Imagindairy … to bring animal-free versions of beloved dairy products like milk, cream cheese and yogurt to consumers nationwide,”​ the company said in the announcement.

With the determination, Imagindairy joins the ranks of Perfect Day, which received a letter of no objections from FDA​ in March 2020 for its animal-free whey made with precision fermentation from a genetically engineered strain of the filamentous fungus Trichoderma reesei, and Remilk which earned self-affirmed GRAS status​ for its beta-lactoglobulin in mid-2022.

Imagindairy’s animal-free dairy protein is made through a combination of precision fermentation that enables microorganisms to be programmed to produce complex organic molecules and a proprietary AI platform, which it says, “integrates both advanced computational biology and molecular biology technologies to enable mass-scale production at costs that are in line with traditional dairy.”​

New headquarters with ‘state-of-the-art’ research & development labs planned​

To support the anticipated partnerships with food and beverage manufacturers and scale-up of its protein, Imagindairy also is opening a new headquarters near Haifa, Israel, which it says will include state-of-the-art RD labs, a test kitchen for culinary and ingredient applications and pilot line.

The new headquarters was made possible thanks in part to a $15m seed expansion around announced in May 2022 following a $13m raise the previous November.

Investors include Target Global, Strauss Group, Emerald Technology Venture, Green Circle Foodtech Ventures, Collaborative Fund, New Climate Ventures and FoodSparks by PeakBridge.

Earlier this year Danone’s corporate venture arm Danone Manifesto Ventures also invested in the startup – taking a minority stake in anticipation of developing strategic collaboration projects.

When the startup announced its seed expansion it also indicated it was in dialogue with several major dairy food producers.

While the headquarters will allow for enhanced product development, Imagindairy will initially rely on contract manufacturing organizations to produce its beta-lactoglobulin.

Imagindairy teams with others in precision fermentation to uplift technology​

While Imagindairy is focused on commercializing its protein in the US, it intends to expand its portfolio and reach in coming years to include Europe.

To further support these efforts, the company helped found the Precision Fermentation Alliance to promote the technology at the center of its production in the US. It also is a founding member of Food Fermentation Europe, which shares similar goals.