Regulatory Compliance: NuCLEANase^® for DNA Removal in Fermentation Products

In fermentative derived products, NuCLEANase^® can be used for the removal of residual DNA from genetically modified production hosts for regulatory compliance.

Microbial fermentation processes are used since thousands of years in food production. The introduction of genetical engineering revolutionized the world of fermentation, enabling the production of proteins that were previously sourced from plants or animals.

Already today, numerous ingredients such as proteins enzymes and flavoring agents are produced by fermentation, a process also known as precision fermentation. Because of its ability to provide sustainable and economically efficient ingredient sourcing, precision fermentation will play an important role in the future of food manufacturing..

Challenge
Despite the huge advantages, manufacturers of fermentative derived products may also face some challenges. Amongst others, the EFSA guidance on dossiers for food enzymes requires the scientific verification of absence of DNA (and the absence of viable cells) when using genetically modified (GM) production strains. This is also required for non-GM production strains carrying acquired AMR genes, to avoid increasing the spread of AMR genes or their adding to the pool of those already present in human gut bacterial population.

Solution
NuCLEANase^® digests all forms of DNA/RNA by catalyzing the hydrolysis of the phosphodiester bonds between nucleotides, leaving short fragments with a length of (2 to 5 base pairs) and is active in broad range of process conditions. This makes the enzyme an attractive option for the removal of residual host DNA, to ensure compliance with regulatory guidelines for the end-product. As the enzyme can be considered as a food processing aid, removal of the enzyme is not required. To further enable an easy implementation in existing processes the food grade version comes with kosher and halal certification.

Secure Compliance with EFSA Regulations Using NuCLEANase^®

Ensure your food enzymes meet EFSA regulations with NuCLEANase^®. This highly active food-grade endonuclease effectively reduces all forms of nucleic acids to smaller nucleotides, ensuring the absence of DNA and viable cells of the production strain. With NuCLEANase^®, you can confidently achieve compliance and safeguard your products.

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