Precision fermentation platform 21st.BIO has earned self-affirmed GRAS status for its animal-free beta-lactoglobulin ingredient, BLG Essential+.
This status means that 21st.BIO’s customers can now launch products using the ingredient in the US market.
This development comes less than two years after 21st.BIO initiated its development of a strain and production process for BLG Essential+. Beta-lactoglobulin (BLG) is the predominant protein in bovine whey and is attractive to food producers due to its high-quality nutrition and advantageous properties in food product formulation.
BLG has more essential and branched-chain amino acids than whey. It contains 45% more leucine than commercially available whey protein isolates, which is particularly important for muscle synthesis, and is tasteless, stable across a wide pH range and can tolerate heat, making it the ideal ingredient for versatile product formulations.
21st.BIO expects its customers’ production of BLG using its precision fermentation platform to be incorporated into the formulation of baked goods and alt-dairy products, as well as nutritional products for active or sports nutrition, weight management and clinical and elderly nutrition.
This self-affirmed GRAS status means that companies engaged in 21st.BIO’s development programme can now commercialise its own production of BLG Essential+ in the US market.
Through 21st.BIO’s BLG programme, customers gain access to the ‘world’s most advanced’ production strains and precision fermentation processes – and benefit from continuous optimisations of strain and process for improved commercial attractiveness. Additionally, 21st.BIO supports its customers in upscaling their production to full-scale ingredient production.
With productive microorganisms licensed from Novonesis (formerly Novozymes), 21st.BIO enables customers to bypass years of development and market approval for direct entry into the US market.
21st.BIO’s co-founder and CSO Per Falholt said: “We bring our customers access to technology and skills they could not get anywhere else".
The firm’s co-founder and CEO Thomas Schmidt added: “We're not just a technology provider – we're a partner to our customers’ on their product journey, ensuring their success from development to full-scale manufacturing. We make products, not projects. Our ambition is to empower our customers to focus more on application, business development, low-cost production and innovation. And this shows all the way through 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.”
21st.BIO’s platform derisks product development and supports customers from strain development, fermentation processes, purification protocols, pilot production and upscaling guidance, to the regulatory approvals for market entry.
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