Company News

21st.BIO’s Precision Fermented Whey for Animal-Free Dairy Obtains US GRAS Status

Danish fermentation upscaling partner 21st.BIO announces that it has earned self-affirmed Generally Recognized as Safe (GRAS) status for its precision fermented beta-lactoglobulin, BLG Essential+.

The GRAS milestone assures that 21st. BIO’s animal-free whey is safe for human consumption, allowing its commercialization within US territory. According to the biotech company, beta-lactoglobulin, the predominant protein in milk’s whey, has garnered significant interest from producers due to its high nutritional quality and beneficial properties for food product formulation.

“Our success at 21st.BIO depends on our customers’ success in the market with a product, not just on project completion”

BLG Essential+ is said to boast essential and branched-chain amino acids, offering 45% more leucine than commercially available whey protein isolates. In addition, it is tasteless, pH-stable, and heat-tolerant, making it easy to incorporate into foods, from alt-dairy to protein drinks to bakery products.

21st.BIO grant access to its precession fermentation platform
© 21st.BIO

Precision-fermented whey for protein suppliers

Founded in 2020, 21st.BIO aims to make industrial-scale precision fermentation technology accessible to advance green transitions globally. Its fermentation technology is partially licensed from Novonesis, the global leader in enzymes and functional proteins, which developed and refined over several decades.

As an integrated end-to-end bioproduction company, 21st.BIO provides customers access to advanced production strains and precision fermentation processes, supporting them from development to full-scale manufacturing. The GRAS status for its animal-free whey means that its customers, dairy protein suppliers, can commercialize their own production of BLG Essential+ in the US market for the new way of animal-free dairy.

Co-founder and CSO Per Falholt comments, “We bring our customers access to technology and skills they could not get anywhere else.”

21st.Bio-co-founders Per Falholt and Thomas Schmidt.
Co-founders Per Falholt (L) and Thomas Schmidt © 21st.BIO

Empowering customers

Headquartered in Copenhagen, Denmark, it has R&D teams and laboratories in Copenhagen and Davis, California. In May, the company inaugurated a new plant in Søborg featuring “state-of-the-art” processing equipment with over 3000 L fermentation capacity. In addition to whey proteins, the firm is working to develop additional recombinant proteins and peptides for food, biomaterials, biopharma, and biomining.

21st.BIO says that scaling beta-lactoglobulin demonstrates its ability to bring products from development initiation to market approval in under two years, showcasing its efficiency and expertise.

Co-founder and CEO Thomas G. Schmidt adds, “Our ambition is to empower our customers to focus more on application, business development, low-cost production, and innovation. This is evident throughout our business model, which is designed such that our success at 21st.BIO depends on our customers’ success in the market with a product, not just on project completion.”

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