21st.BIO Secures GRAS Status for Innovative Protein Ingredient
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21st.BIO Achieves Self-Affirmed GRAS Status
21st.BIO is thrilled to announce its groundbreaking achievement of obtaining self-affirmed GRAS (Generally Recognized As Safe) status for its innovative, animal-free beta-lactoglobulin ingredient, known as BLG Essential+™. This significant milestone enables the company's customers to successfully introduce their products into the U.S. market, harnessing the power of 21st.BIO's advanced technology.
Accelerated Market Entry for Customers
With an unprecedented focus on rapid development, 21st.BIO empowers its customers to transition from the conceptual phase to market approval within an impressive timeframe of under two years. This extraordinary efficiency is made possible by the company’s specialized expertise in precision fermentation technology—a field in which 21st.BIO has honed its processes through years of dedicated research and development.
About BLG Essential+
At the heart of this breakthrough is BLG Essential+™, a high-quality recombinant beta-lactoglobulin derived through meticulous scientific study of cow's milk protein variations. This unique protein is not only one of the most concentrated sources of whey protein but is also known for its superior nutritional benefits and functional versatility.
Exceptional Nutritional Benefits
Beta-lactoglobulin is recognized as a powerful and nutrient-rich dairy protein. Its notable appeal lies in its impressive nutritional profile which includes:
- A remarkable 45% higher leucine content compared to traditional whey protein isolates, particularly beneficial for muscle synthesis.
- Stability across a variety of pH levels and heat tolerance, making it suitable for an extensive range of product formulations, from clear protein drinks to dairy alternatives and baked goods.
With its unique properties, 21st.BIO anticipates that customers will incorporate BLG Essential+™ into a diverse array of food products, including bakery items, alternative dairy products, and various nutritional offerings aimed at sports nutrition, weight management, and dietary support for the elderly.
Innovative Business Model for Collaboration
21st.BIO's distinctive business model stands out in the industry—providing a single market approval that allows multiple dairy protein suppliers to commercialize their own production of BLG Essential+™. By participating in 21st.BIO’s specialized BLG program, customers access cutting-edge production strains and precision fermentation processes that evolve over time. This structure facilitates seamless scaling of production from pilot batches to full-scale manufacturing.
A Commitment to Customer Success
According to Per Falholt, co-founder and CSO of 21st.BIO, “We provide our customers with access to technology and expertise they cannot find elsewhere.” Thomas Schmidt, co-founder and CEO, emphasizes that the company strives to be more than just a technology provider, describing their role as a true partner in the product development journey. They prioritize enabling customers to concentrate on application, business growth, and innovation rather than merely project completion.
Comprehensive Support for Product Development
21st.BIO simplifies the product development process by offering comprehensive support at every stage, including strain development, fermentation, purification, pilot production, and regulatory approvals necessary for market entry. The company is dedicated to expanding its offerings to include additional protein innovations for various industries such as food, materials, and agriculture.
About 21st.BIO
Founded in 2020 and headquartered in Copenhagen, 21st.BIO aims to democratize access to its leading precision fermentation technology, empowering companies worldwide to bring biotech innovations to market affordably. The founders recognized the challenge of financial hurdles in moving innovations from development to commercial success, coining this crisis the "valley of death." 21st.BIO's mission is to bridge that gap, ensuring that groundbreaking bio innovations can reach a broader market.
With exceptional R&D capabilities and a team residing in both Copenhagen and Davis, California, 21st.BIO is committed to advancing the global green transition. Their ongoing efforts focus on optimizing and developing industrial production technologies for proteins and molecules that address contemporary food and agricultural needs.
Frequently Asked Questions
What is GRAS status?
GRAS status means that a substance is considered safe for consumption based on its long history of use or scientific evidence, enabling manufacturers to bring products to market more swiftly.
How does 21st.BIO's technology work?
21st.BIO uses precision fermentation technology to produce proteins like beta-lactoglobulin efficiently and sustainably, leveraging advanced microbial strains and processes.
What products can incorporate BLG Essential+™?
The protein can be used in a variety of food products, including protein drinks, dairy alternatives, baked goods, and nutritional supplements.
How does 21st.BIO support its customers?
21st.BIO offers extensive support, including technology access, production scaling guidance, and help with regulatory approvals to ensure successful product launches.
What is the benefit of using BLG Essential+™ over traditional whey proteins?
BLG Essential+™ provides a higher concentration of essential amino acids, particularly leucine, and offers greater versatility in product formulation compared to traditional whey proteins.
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