Copenhagen, Denmark, and Davis, California, – 21st.BIO, a leading provider of precision fermentation technology, announces a major safety milestone with the publication of a peer-reviewed study showcasing the world’s first fully mycotoxin-free Aspergillus oryzae strain lineage for industrial protein production. The breakthrough further strengthens the foundation for cost-effective production of novel food proteins at scale using filamentous fungi.  

Redefining the gold standard in precision fermentation 

21st.BIO unveils that its proprietary strain lineage was engineered to eliminate all known mycotoxin biosynthesis pathways. This addresses a long-standing challenge in using filamentous fungi for food – the potential for mycotoxin contamination – and opens the door for safer, more broadly accepted protein ingredients made with precision fermentation. 

Filamentous fungi such as A. oryzae are increasingly favored over bacteria and yeasts in industrial fermentation due to their ability to deliver higher protein titers, robust growth on inexpensive and renewable feedstocks, and an efficient fermentation process that scales easily. These advantages make fungi particularly appealing for the food and feed industries, where large-scale production of cost-effective, sustainable, and functional proteins is crucial.  

The study – published in Applied Microbiology and Biotechnology [1] – describes how this proprietary strain lineage was engineered to eliminate all known mycotoxin biosynthesis pathways, including gene clusters for aflatoxins, cyclopiazonic acid, and 3-nitropropionic acid. Additional modifications removed the penicillin G cluster, ensuring that the strain does not produce antibiotics or other unintended secondary metabolites. With its long history of safe use, its clean safety profile, and strong industrial performance, this lineage offers a new gold standard in the production of precision-fermented proteins. 

21st.BIO enables protein innovation through precision fermentation. The company makes industrial-scale fermentation accessible to biotech and food companies by providing a full suite of services, including strain development, fermentation process optimization, tech transfer, and regulatory support. With a focus on ensuring cost-effective, sustainable, and scalable production, 21st.BIO helps customers bring novel biotech innovations to market efficiently. 21st.BIO supports a wide range of industries, from food and agriculture to materials, by enabling the large-scale production of high-value proteins and other molecules. 

“This breakthrough is not just a scientific achievement — it’s a game-changer for our customers,” says José Arnau, Executive Director of Strain Development and Regulatory Affairs at 21st.BIO, and author of the study. “By eliminating the last safety challenge around filamentous fungi, we’re unlocking the full industrial potential of A. oryzae for food protein production. It’s for example the foundation behind our beta-lactoglobulin program, which achieved a GRAS self-affirmation status in record time and is already supporting partners preparing to launch products in the US. It should also entail a faster process for approval in Europe. With the strain lineage of 21st.BIO, companies can move from lab to market faster than ever — without compromising on safety or scalability.” 

A call for regulatory modernization in Europe 

21st.BIO offers this technology as part of a full development program – enabling partners to access safe, high-yield production strains, scalable processes, and regulatory support. With self-affirmed GRAS status already achieved in the United States for beta-lactoglobulin (BLG) produced using this strain, the technology is now being adopted by several companies, soon preparing to bring precision-fermented BLG products to market.  

The same strain lineage is now being applied to new development programs, including highly demanded dairy proteins like caseins, as well as a growing number of applications across food, agriculture, and biomaterials. 

Given the maturity and now also the documented safety of this technology – we hope it is time for the European Union to modernize its regulatory frameworks. The current QPS (Quality Presumption of Safety) model excludes filamentous fungi and limits evaluation to the species level. As demonstrated in this study, today’s tools enable precise, strain-level safety assessment based on genomic sequencing and comprehensive molecular understanding. Updating the QPS framework to include rigorously developed fungal strains would unlock faster, science-based approval pathways and support the growth of safe, sustainable protein innovation in Europe. 

21st.BIO calls on regulators to recognize this opportunity and align safety frameworks with the capabilities of modern biotechnology – for the benefit of innovation, consumer safety, and the global green transition. 

^[1] Lehmbeck, J., Andersen, B., Sáez-Sáez, J., Frisvad, J.C., and Arnau, J. Mycotoxin-free Aspergillus oryzae strain lineage for alternative and novel protein production at industrial scale. Appl Microbiol Biotechnol 109, 94 (2025). https://doi.org/10.1007/s00253-025-13482-6 

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 focuses on developing industrial production technology for proteins and other molecules of interest for food, nutrition, agriculture, biomaterials, and biomining industries.  

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.  

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 partly licensed from Novonesis, which has 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.