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FDA Grants GRAS Approval to Imagindairy and Company Acquires Industrial-Scale Precision Fermentation Lines

Imagindairy receives GRAS nod from FDA, acquires industrial-scale precision fermentation lines

The company made an announcement today regarding the receipt of a “no questions” response letter from the FDA for its GRAS notice submitted last summer. The notice pertained to the animal-free whey protein β-lactoglobulin produced by Aspergillus oryzae strain Ao_st0002 (GRN 1145).

The FDA’s tacit approval in response to Imagindairy’s GRAS self-determination implies that the ingredient can be incorporated into various products in the United States at levels ranging from 5-35%. These products include milk and milk-based items such as yogurt, cheeses, creams, and spreads, as well as dairy-based frozen desserts and mixes. Additionally, the approval extends to nutritional bars, beverages, meal replacements, and supplements.

FDA Grants GRAS Approval to Imagindairy and Company Acquires Industrial-Scale Precision Fermentation Lines

FDA Grants GRAS Approval to Imagindairy and Company Acquires Industrial-Scale Precision Fermentation Lines (Credits: Food Navigator)

Imagindairy becomes the third company to receive a coveted “no questions letter” from the FDA for an animal-free whey protein. Perfect Day obtained a similar letter of no objection in March 2020 for its animal-free whey produced through precision fermentation from a genetically engineered strain of the filamentous fungus Trichoderma reesei. Remilk also received a “no questions letter” from the FDA in February for the production of animal-free whey produced by Komagataella phaffii strain “yRMK-66.”

Imagindairy employs precision fermentation and a proprietary AI platform to create its animal-free dairy products. With the recent acquisition of its industrial-scale precision fermentation production lines, the company aims to achieve cost parity with traditional dairy in the production and sale of its animal-free milk proteins.

The newly acquired facility provides Imagindairy with access to over 100,000 liters of fermentation capacity dedicated exclusively to animal-free milk protein production. This move is expected to expedite the development of other milk proteins, and the company plans to triple its production volume within the next one or two years.

Imagindairy’s acquisition addresses production capacity limitations that have affected various industries relying on precision fermentation. While many companies use redesigned pharmaceutical facilities, which may limit scalability and cost efficiency, Imagindairy claims to be producing industrial-scale batches at a competitive cost structure compared to traditional dairy.

Eyal Afergan, co-founder and CEO of Imagindairy, asserts that the acquisition will support mass-market adoption, facilitate the transition to an industrial company, and accelerate the development of other milk proteins.

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