Precision fermentation innovator 21st.BIO has achieved a significant milestone, earning self-affirmed GRAS (Generally Recognized As Safe) status for its animal-free beta-lactoglobulin ingredient, BLG Essential+™. This approval clears the path for the ingredient's launch in the United States, signaling a major breakthrough for the company and its partners.

Rapid Development and Market Entry

Less than two years after beginning the development of its beta-lactoglobulin protein, BLG Essential+™, 21st.BIO has demonstrated the efficiency of its cutting-edge precision fermentation platform. This rapid progress underscores the company's unique expertise and ability to bring innovative solutions to market at an unprecedented pace.

The Power of Beta-Lactoglobulin

Beta-lactoglobulin, the primary protein found in bovine whey, has garnered attention from food producers due to its superior nutritional profile and versatile application potential. This dairy protein is rich in essential and branched-chain amino acids, making it a valuable ingredient in various food formulations. Notably, BLG Essential+™ contains 45% more leucine than standard whey protein isolates, a critical component for muscle synthesis.

In addition to its nutritional benefits, BLG Essential+™ is tasteless, stable across a wide pH range, and heat-tolerant, making it an ideal ingredient for products ranging from clear protein drinks to alternative dairy and bakery goods. 21st.BIO anticipates that its customers will incorporate this protein into foods such as baked goods, dairy alternatives, and nutritional products designed for active lifestyles, weight management, and specialized dietary needs.

A Unique Business Model for Market Success

21st.BIO's innovative business model allows its customers to capitalize on the GRAS status of BLG Essential+™ and commercialize their production in the U.S. market. By participating in 21st.BIO's BLG program, customers gain access to world-class production strains and precision fermentation processes, with continuous improvements over time. The company also offers comprehensive support, helping customers scale from pilot production to full-scale manufacturing.

The company's global customer base includes food-tech startups and large ingredient manufacturers, all benefiting from 21st.BIO's commitment to getting products to market quickly and efficiently. BLG Essential+™ is the first of many food protein ingredients that 21st.BIO plans to introduce this model.

Empowering Customers with Advanced Solutions

Leveraging productive microorganisms licensed from Novonesis (formerly Novozymes), 21st.BIO enables customers to bypass the lengthy development and approval processes typically required for market entry. This approach allows customers to focus on innovation and application, confident that 21st.BIO will support them through every stage of product development.

"We bring our customers access to technology and skills they could not get anywhere else," says 21st.BIO co-founder and CSO Per Falholt. CEO Thomas G. Schmidt adds, "We're not just a technology provider—we're a partner on our customers' product journey, ensuring their success from development to full-scale manufacturing. Our business model is designed so that our success is directly tied to our customers' success in the market."

21st.BIO's comprehensive support extends from strain development and fermentation processes to purification protocols, pilot production, and regulatory guidance. As the company continues to innovate, it is working on additional proteins for applications in food, materials, agriculture, and beyond, further solidifying its position as a leader in the precision fermentation space.