21st.BIO obtains self-affirmed GRAS status for its precision fermented beta-lactoglobulin: 21st.BIO customers can now enter the U.S. market with their own production using 21st.BIO technology

• 21st.BIO has earned a self-affirmed GRAS status for its animal-free beta-lactoglobulin ingredient, which customers can now launch in the United States market.
• 21st.BIO is helping customers bring products to market at an unprecedented pace, from initiation of development to market approval in under two years.
• 21st.BIO offers the leading production technology for BLG, based on precision fermentation technology that has been perfected over decades and partly licensed from Novonesis (formerly Novozymes).
• By studying the variation in cows’ milk protein, 21st.BIO’s world class scientists have been able to reproduce a highly nutritious recombinant BLG, which is the most potent bovine whey protein and has superior nutrition and functionalities. This is why 21st.BIO has named its protein BLG Essential+™.

COPENHAGEN, Denmark and DAVIS, Calif., Sept. 4, 2024 /PRNewswire/ — Precision fermentation platform provider 21st.BIO has earned a self-affirmed GRAS status for its animal-free beta-lactoglobulin ingredient, BLG Essential+™, which means customers can now launch in the United States market.

This breakthrough comes less than two years after 21st.BIO initiated its development of a strain and production process for its beta-lactoglobulin protein, BLG Essential+™, demonstrating the power of the Company’s approach, unique expertise and differentiated precision fermentation platform.

Beta-lactoglobulin is a potent and highly nutritious dairy protein  

The predominant protein in bovine whey, beta-lactoglobulin (BLG) has attracted considerable food-producer interest for its high-quality nutrition and advantageous properties in food product formulation.

Its nutritional profile is impressive, boasting a larger amount of essential and branched-chain amino acids than whey. For example:

• BLG contains 45% more leucine than commercially available whey protein isolates, which is particularly important for muscle synthesis.
• BLG is tasteless, stable across a wide pH range and can tolerate heat, making it the ideal ingredient for versatile product formulations, from clear protein drinks to alternative dairy or bakery products.

21st.BIO expects its customers’ own production of beta-lactoglobulin to be incorporated into the formulation of foods such as baked goods and alternative dairy products, as well as nutritional products for active or sports nutrition, weight management, and clinical and elderly nutrition.

Unique business model: One market approval for several dairy protein suppliers 

Companies engaged in 21st.BIO’s unique development program can now commercialize their own production of BLG Essential+™ in the U.S. market. Through 21st.BIO’s BLG program, customers gain access to the world’s most advanced production strains and precision fermentation processes – and optimizations over time. Furthermore, 21st.BIO is supporting customers in upscaling their production all the way to full-scale ingredient production. The Company’s diverse global customer base spans food-tech start-ups to large food ingredients manufacturers. BLG Essential+™ is the first food protein out of a portfolio of protein ingredients that 21st.BIO will take to the market via this model. 

21st.BIO gets solutions to market at an unprecedented pace 

With a strong track record and productive microorganisms licensed from Novonesis (formerly Novozymes), 21st.BIO is bringing solutions to market at an unprecedented pace, enabling customers to bypass years of development and market approval for direct entry into the U.S. market and empowering customers to produce any food, materials, agriculture, or biopharma-related protein or peptide of interest, and scale production to industrial levels to ensure large-scale availability and cost-effectiveness. Customers in 21st.BIO’s development programs benefit from continuous optimizations of strain and process for improved commercial attractiveness.

Comprehensive support every step of the way to get products to market 

“We bring our customers access to technology and skills they could not get anywhere else,” said 21st.BIO co-founder and CSO Per Falholt. 

And 21st.BIO co-founder and CEO Thomas G. Schmidt continues: “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 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. 21st.BIO is working on additional proteins, including proteins for both foods, materials, agriculture and beyond.

NOTES TO EDITORS 

About 21st.BIO  

21st.BIO was founded with one simple mission: to make leading industrial scale precision fermentation technology accessible to as many as possible, so companies can successfully take biotech innovations to market at a competitive price. 21st.BIO’s founders saw that too often, great bio innovation and molecules fail to translate into commercial success. The innovation is ready, the market is there, but production costs remain too high for the product to go mainstream. Industry insiders call it the `valley of death’, and that’s exactly what 21st.BIO intends to bridge. 

Founded in 2020, 21st.BIO is headquartered in Copenhagen, Denmark, and has a world-class R&D team as well as laboratories in both Copenhagen, Denmark and Davis, California. On a mission to support bio industrial companies globally in upscaling from molecule innovation to large-scale production, 21st.BIO enables its customers to meet market demands, and thereby advance the green transition globally. 21st.BIO focuses on developing industrial production technology for proteins and other molecules of interest for food, materials, and agricultural industries. Established as a fully integrated end-to-end partner, 21st.BIO supports its customers from technical assessment, strain development and optimization, production processes and upscaling, tech transfer to large scale manufacturing and regulatory services.  

21st.BIO’s fermentation technology is in part licensed from Novonesis, who have developed and perfected their platform over several decades. Novonesis is a global leader in enzymes, functional proteins and microorganisms for high value products in food, household care, and agriculture.  

Press contact:
Mathilde Pinon
Marketing & Business Development Manager
m.pinon@21st.bio

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