21st.BIO Achieves Self-Affirmed GRAS Status
21st.BIO is excited to share that it has achieved self-affirmed GRAS (Generally Recognized As Safe) status for its innovative, animal-free beta-lactoglobulin ingredient, known as BLG Essential+™. This important milestone allows the company’s customers to effectively launch their products in the U.S. market, leveraging the advanced technology developed by 21st.BIO.
Accelerated Market Entry for Customers
With an exceptional emphasis on rapid development, 21st.BIO enables its customers to move from the idea stage to market approval in less than two years. This remarkable speed is made possible by the company’s expertise in precision fermentation technology, which has been refined through years of dedicated research and development.
About BLG Essential+
At the core of this achievement is BLG Essential+™, a high-quality recombinant beta-lactoglobulin produced through careful scientific analysis of cow's milk protein variations. This unique protein stands out as one of the most concentrated sources of whey protein, renowned for its exceptional nutritional benefits and functional versatility.
Exceptional Nutritional Benefits
Beta-lactoglobulin is celebrated as a potent and nutrient-rich dairy protein. Its appeal is largely due to its impressive nutritional profile, which includes:
- A remarkable 45% higher leucine content compared to traditional whey protein isolates, making it particularly beneficial for muscle synthesis.
- Stability across various pH levels and heat tolerance, which makes it suitable for a wide range of product formulations, including clear protein drinks, dairy alternatives, and baked goods.
Given its unique properties, 21st.BIO expects that customers will incorporate BLG Essential+™ into a diverse selection of food products, ranging from bakery items to alternative dairy products and nutritional offerings designed for sports nutrition, weight management, and dietary support for the elderly.
Innovative Business Model for Collaboration
21st.BIO's distinctive business model sets it apart in the industry by providing a single market approval that allows multiple dairy protein suppliers to commercialize their own production of BLG Essential+™. By joining 21st.BIO’s specialized BLG program, customers gain access to advanced production strains and precision fermentation processes that evolve over time. This model facilitates a smooth transition from pilot batches to full-scale manufacturing.
A Commitment to Customer Success
Per Falholt, co-founder and CSO of 21st.BIO, states, “We provide our customers with access to technology and expertise they cannot find elsewhere.” Thomas Schmidt, co-founder and CEO, adds that the company aims to be more than just a technology provider; they see themselves as true partners in the product development journey. Their focus is on enabling customers to concentrate on application, business growth, and innovation rather than just completing projects.
Comprehensive Support for Product Development
21st.BIO streamlines the product development process by offering extensive support at every stage, including strain development, fermentation, purification, pilot production, and the regulatory approvals needed for market entry. The company is committed 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 based in Copenhagen, 21st.BIO is dedicated to democratizing access to its leading precision fermentation technology, allowing companies worldwide to bring biotech innovations to market at an affordable cost. The founders recognized the financial challenges that often hinder the transition of innovations from development to commercial success, coining this issue the "valley of death." 21st.BIO's mission is to bridge that gap, ensuring that groundbreaking bio innovations can reach a wider audience.
With outstanding R&D capabilities and a team located in both Copenhagen and Davis, California, 21st.BIO is committed to advancing the global green transition. Their ongoing initiatives focus on optimizing and developing industrial production technologies for proteins and molecules that address current food and agricultural needs.
Frequently Asked Questions
What is GRAS status?
GRAS status indicates that a substance is deemed safe for consumption based on its historical use or scientific evidence, allowing manufacturers to bring products to market more quickly.
How does 21st.BIO's technology work?
21st.BIO employs precision fermentation technology to produce proteins like beta-lactoglobulin in an efficient and sustainable manner, utilizing advanced microbial strains and processes.
What products can incorporate BLG Essential+™?
This protein can be used in a variety of food products, such as protein drinks, dairy alternatives, baked goods, and nutritional supplements.
How does 21st.BIO support its customers?
21st.BIO provides extensive support, including access to technology, guidance on scaling production, and assistance with regulatory approvals to ensure successful product launches.
What is the benefit of using BLG Essential+™ over traditional whey proteins?
BLG Essential+™ offers a higher concentration of essential amino acids, especially leucine, and provides greater versatility in product formulation compared to traditional whey proteins.
