Biotech firm 21st.BIO has developed a new strain of Aspergillus oryzae, a filamentous fungus commonly used in fermentation, that has been engineered to remove all known pathways for producing mycotoxins — potentially harmful compounds sometimes found in fungi.
“This breakthrough is not just a scientific achievement — it’s a game-changer for our customer”
The new strain, described in a peer-reviewed study published in Applied Microbiology and Biotechnology, was designed to avoid producing substances such as aflatoxins and other unwanted byproducts. It also eliminates the genes responsible for penicillin G production, which reduces the risk of unintended antibiotic residues.
According to the study’s lead author, José Arnau, Executive Director of Strain Development and Regulatory Affairs at 21st.BIO, the work removes a longstanding safety concern in fungal-based production systems. “By eliminating the last safety challenge around filamentous fungi, we’re unlocking the full industrial potential of A. oryzae for food protein production,” he said.
Unlocking industrial potential
Filamentous fungi are gaining popularity in fermentation-based protein production thanks to their ability to deliver higher yields and grow on low-cost, renewable materials. However, concerns over mycotoxins have historically slowed their adoption in food applications. This newly developed strain addresses those concerns and is already being used in the production of beta-lactoglobulin, a whey protein analogue that has received self-affirmed GRAS (Generally Recognized As Safe) status in the United States.
Several companies are now preparing to bring products using this protein to market. 21st.BIO is also applying the same strain to develop other dairy proteins such as caseins, as well as to explore uses in agriculture and sustainable materials.
Calls for regulatory reform in the EU
The company is urging regulators in the European Union to update current safety frameworks, which do not yet account for strain-level differences in fungi. Under the EU’s Qualified Presumption of Safety (QPS) system, entire fungal species can be excluded regardless of the specific strain’s characteristics.
“Today’s tools enable precise, strain-level safety assessment based on genomic sequencing and comprehensive molecular understanding. It should also entail a faster process for approval in Europe,” Arnau said.
Founded in 2020, 21st.BIO operates research and development facilities in Copenhagen and Davis, California. The company provides end-to-end support for biotech firms, including strain development, fermentation process design, and regulatory services. Its core technology is partly licensed from Novonesis, a long-standing player in microbial production platforms.
The newly validated fungal strain is already being used in the company’s pilot facility in Denmark and forms the basis for ongoing protein development programs targeting food, feed, and biomaterials markets.
In an announcement, the company stated, “Why is this so important? Because the world – including Europe – needs more protein. Not to replace the cow, but to secure enough high-quality nutrition. Europe has the world’s leading technology to produce proteins with precision fermentation.”
