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Sep 04

21st.BIO obtains self-affirmed GRAS status for its precision fermented beta-lactoglobulin

By Dairy proteins, Press releases

As featured in

  • 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, California, 4 September 2024 – 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.

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.

For more information and pictures of the day, please contact:

Mathilde Pinon
Marketing & Business Development Manager
+4531543184
m.pinon@21st.bio

May 06

21st.BIO unveils a new pilot plant facility to accelerate impact of biotech innovations globally

By Biomaterials, Dairy proteins, Events, Partnerships, Press releases, Public affairs

As featured in

  • Combining world-class industrially proven technology with fermentation capacity, 21st.BIO helps customers get to scale faster, in a risk-mitigated and cost-effective way.
  • Margrethe Vestager, Executive Vice President of the European Commission, was onsite to inaugurate the pilot facility, along a hundred other guests from the financial, political, and bio industrial sectors.

 

Copenhagen, Denmark, and Davis, California, 6 May 2024 – 21st.BIO unveiled a new pilot plant facility in its Danish headquarters, designed to support companies upscale their bioproduction.

21st.BIO provides services ranging from strain construction to industrial production upscaling to customers worldwide. Combining world-class industrially proven technology with fermentation capacity, the company will help customers get to scale faster, in a risk-mitigated and cost-effective way.

From left to right: Thomas Schmidt, co-founder and CEO at 21st.BIO, Margrethe Vestager, Executive Vice President of the European Commission, and Per Falholt, co-founder and CSO at 21st.BIO, unveiled 21st.BIO’s pilot plant facility

 

Why do we need pilot facilities? Upscaling mistakes cost a lot of money and time

“In this industry, upscaling mistakes cost a lot of money and time,” explains Thomas Schmidt, co-founder, and CEO at 21st.BIO. “For our customers, it’s all about getting the next step right. The ability to increase productivity when also moving up in scale is what distinguishes good from great.”

21st.BIO offers this pilot facility to the market to facilitate and accelerate the step between internal lab-scale fermentation and large-scale production. 21st.BIO’s pilot construction and deep experience are ideal to define the important parameters and equipment needed for optimal large-scale production of proteins via fermentation. This will, on top of the best fermentation protocols, for example also help customers select the best CMO for individual project needs and limit the risk of costly failures.

21st.BIO’s pilot facility is designed for industrial production upscaling

The facility and all processing equipment are state-of-the-art, with much equipment designed for 21st.BIO.

“Our goal with this pilot was to build a mini factory, to best prepare customers for large scale industrial production. We therefore wanted the process equipment to mimic what customers will find in their next step with large-scale biomanufacturing – only downsized to a pilot scale,” explains Thorvald Ullum, Chief Technology Officer at 21st.BIO. He adds “our customers work alongside our experts in the pilot plant to test various process aspects as well as build skills and confidence for their own large-scale production.”

With over 3000 liters of fermentation capacity, the facility offers a full range of capabilities, equipment, and competences to help customers optimize their own specific processes. The pilot plant is focused on scaling up the production of recombinant proteins and peptides with applications in nutrition, food and beverages, agriculture, biomaterials, and biopharma.

The pilot plant is designed to enable strong collaboration between 21st.BIO and customer teams during scaling. The facility is strategically located in the same building as the company’s strain development laboratories, allowing for joint work on further improving the customers’ production strains and fermentation processes.

21st.BIO’s pilot welcomes established industry leaders in ingredient manufacturing as well as early-stage startups.

The global race for biosolutions is on

Home to precision fermentation pioneers such as Novo Nordisk and Novonesis, Denmark is a natural leader in bioproduction. According to a McKinsey report, it is estimated that about 60% of the input to the global economy could over time be produced using biology. Because of this potential, many countries are investing massively in biomanufacturing technology to produce high quality nutrition and biomaterials locally in a time of climate and geo-political uncertainties.

Europe has an opportunity to bring this leading technology and know-how to benefit the world. Therefore, 21st.BIO’s grand opening began with an exclusive roundtable, where twenty C-level participants from the political, financial, and industrial horizons had a lunch conversation over EU countries’ leadership in the industrial scaling of biomanufacturing.

Margrethe Vestager, Executive Vice President of the European Commission, attended the event and underlined the high potential of the biotech sector to address key challenges ranging from ensuring sustainability to stabilising global food chains. She emphasised Europe’s leadership in science, while acknowledging that taking science to markets is often hindered by lack of sufficient funding, long regulatory procedures, and a reduced talent pool. She also called for cooperation between policy makers and industry players to ensure that policies are designed while taking into account the industry’s lessons learnt.

Earlier in March, the European Commission presented its “Communication on Biotech and Biomanufacturing” and with that a series of actions to boost the sector in the EU. This includes working towards simplified regulatory framework and faster access to market, better support for scale-up, a fairer comparison with fossil-based products, and the encouragement for more investments to go into biotechnologies and biomanufacturing in the coming years.

As Margrethe Vestager said during the press conference, “Europe cannot just be the cradle for new solutions, what is born here should also grow up and stay here.”

Ambitions for enabling the building of large-scale protein facilities across the world

21st.BIO founders saw that too often; great bio innovations and molecules fail to translate into commercial success. The molecule innovation is ready and exciting, the market is there, but production costs most often have remained too high for the products to go mainstream and hence have real relevance for the world.

A recent report by Boston Consulting Group highlighted that three parameters were key to get down the cost of bioproducts: Production strains designed for scale, mega scale factories of over two million liters capacity, and mass market demand. This is what 21st.BIO is all about.

21st.BIO is now making the most advanced and most productive production technology and know-how available to innovators in industrial biotech as well as global food majors for bulk products to be produced via fermentation. The pilot facility will support customers’ journey from the lab to large scale manufacturing, but the journey towards industrial biomanufacturing does not stop there. During the inauguration, senior leaders from key players of the financial, political, and industrial sectors participated in a roundtable discussion on what it will take to start building the first large-scale protein factories with all the benefits of industrial manufacturing to cost and efficiency.

About 21st.BIO

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 was founded with one simple mission: to make industrial scale precision fermentation technology accessible to as many as possible, so companies can successfully take their biotech innovations to market at a competitive price.

21st.BIO’s fermentation technology is in part licensed from Novonesis, who has developed their platform over several decades. Novonesis is a global leader in enzymes and proteins for high value products in food, household care, and agriculture, with a market value of approximately 6 billion USD.

For more information and pictures of the day, please contact:

Mathilde Pinon
Marketing & Business Development Manager
+4531543184
m.pinon@21st.bio

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