The corporate introduced right this moment that it acquired from FDA final month a “no questions” response letter for the GRAS discover it submitted final summer season for its animal-free whey protein β-lactoglobulin produced by Aspergillus oryzae pressure Ao_st0002 (GRN 1145).
The tacit greenlight implied in FDA’s response to Imagindairy’s GRAS self-determination means the ingredient can be utilized at ranges ranging rom 5-35% within the US in merchandise starting from milk and milk-based merchandise, resembling yogurt, cheeses, lotions and spreads, to dairy-based frozen desserts and mixes to dietary bars and drinks in addition to meal replacements and dietary supplements.
Imagindairy is the third firm to obtain a hard-to-obtain “no questions letter” from FDA for an animal-free whey protein. Good Day earlier acquired a letter of no objection from FDA in March 2020 for its animal-free whey made with precision fermentation from a genetically engineered pressure of the filamentous fungus Trichoderma reesei, and Remilk, which acquired a “no questions letter” from FDA final February for the manufacturing of animal-free whey produced by Komagataella phaffii pressure “yRMK-66”.
Imagindairy makes its animal-free dairy by way of a mixture of precision fermentation and a proprietary AI platform, which together with its acquisition of its personal industrial-scale precision fermentation manufacturing strains, introduced right this moment, will enable the corporate to make and promote its animal-free milk proteins at price parity to conventional dairy, in line with the corporate.
Industrial scale manufacturing will ‘pace up the event of different milk proteins’
The power offers Imagindairy entry to greater than 100,000 liters of fermentation capability that the corporate says it would dedicate solely to animal-free milk protein manufacturing.
With plans to triple manufacturing quantity within the subsequent one or two years, Imagindairy’s acquisition permits the corporate to beat cussed manufacturing capability limitations which have precipitated bottlenecks throughout classes counting on precision fermentation.
Many corporations that depend on precision fermentation are utilizing redesigned pharmaceutical services, which aren’t as environment friendly as they may very well be – limiting their potential to scale manufacturing past bench quantities or to a worth level that’s viable. Nevertheless, some are starting to construct out manufacturing capability.
However Imagindairy claims to already be producing industrial scale batches in its lately acquired facility and at a “aggressive price construction to conventional dairy.”
By enabling corporations to carry animal-free dairy merchandise to market at price parity to conventional dairy, Imagindairy co-founder and CEO Eyal Afergan provides the acquisition “will enable us to assist mass-market adoption, transition to an industrial firm, and pace up the event of different milk proteins.
