The company announced today that it received from FDA last month a “no questions” response letter for the GRAS notice it submitted last summer for its animal-free whey protein β-lactoglobulin produced by Aspergillus oryzae strain Ao_st0002 (GRN 1145).
The tacit greenlight implied in FDA’s response to Imagindairy’s GRAS self-determination means the ingredient can be used at levels ranging rom 5-35% in the US in products ranging from milk and milk-based products, such as yogurt, cheeses, creams and spreads, to dairy-based frozen desserts and mixes to nutritional bars and beverages as well as meal replacements and supplements.
Imagindairy is the third company to receive a hard-to-obtain “no questions letter” from FDA for an animal-free whey protein. Perfect Day previous received a letter of no objection 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 received a “no questions letter” from FDA last February for the production of animal-free whey produced by Komagataella phaffii strain “yRMK-66”.
Imagindairy makes its animal-free dairy through a combination of precision fermentation and a proprietary AI platform, which in combination with its acquisition of its own industrial-scale precision fermentation production lines, announced today, will allow the company to make and sell its animal-free milk proteins at cost parity to traditional dairy, according to the company.
Industrial scale manufacturing will ‘speed up the development of other milk proteins’
The facility gives Imagindairy access to more than 100,000 liters of fermentation capacity that the company says it will dedicate solely to animal-free milk protein production.
With plans to triple production volume in the next one or two years, Imagindairy’s acquisition allows the company to overcome stubborn production capacity limitations that have caused bottlenecks across categories relying on precision fermentation.
Many companies that rely on precision fermentation are using redesigned pharmaceutical facilities, which are not as efficient as they could be – limiting their ability to scale production beyond bench amounts or to a price point that is viable. However, some are beginning to build out production capacity.
But Imagindairy claims to already be producing industrial scale batches in its recently acquired facility and at a “competitive cost structure to traditional dairy.”
By enabling companies to bring animal-free dairy products to market at cost parity to traditional dairy, Imagindairy co-founder and CEO Eyal Afergan adds the acquisition “will allow us to support mass-market adoption, transition to an industrial company, and speed up the development of other milk proteins.