Frequently Asked Questions about NuCLEANase^®

The volumetric activity varies per batch and the filling volume will be adapted accordingly. This means that the filling volume for the same amount of activity can be different. c-LEcta guarantees a minimum of ≥ 30 MU/L, as specified in the Product Specification document. The delivered volume will exactly contain the ordered amount of NuCLEANase^® activity or a bit more.  

Two standard packages of 3 MU and 15 MU are available for sampling application and can also be ordered here. For other quantities, please inform us about your demand and we will sent you a quotation as soon as possible.  

*Please note that per company policy we sell our product in Units amount. 

Depending on the conditions and application NuCLEANase^® can be added at any stage in your process. For applications with high nucleic acid concentrations, that often lead to viscosity increases and aggregate formations, it is recommended to add the enzyme just before or after the moment that the nucleic acids are released. In this way the recovery of your product can be optimized. For fermentation processes this is usually during the lysis step or just before the start of the downstream process.  

The required amount of enzyme differs per application and is depending on factors such as the nucleic acid concentration and the available digestion time. In addition, process conditions such as temperature, pH and the salt concentration also impact the enzyme activity and for this reason the optimal enzyme concentration needs to be determined per application.  

Guidance: For high nucleic acid concentrations after fermentation processes, we recommend starting at use levels of NuCLEANase^® of 250 kU/kg of wet biomass (ca. 100 kU/L fermentation broth) and then adjust according to your specific process conditions.  

NuCLEANase^® is a food grade processing aid for the removal of nucleic acids. In the final product NuCLEANase^® will not exert any technical function and according to the Enzyme Regulation (EC) No 1334/2008 of this reason NuCLEANase^® does not to be removed from your final product.   

There is no strict regulatory need to remove NuCLEANase^® from your final food product.  However, in most cases NuCLEANase^® will be used at an early stage in the manufacturing process and the enzyme activity will be reduced or removed because of the subsequent downstream process steps. 

If irreversible enzyme removal is desired, the following process steps and conditions can be recommended:
 At 48°C or above the enzyme activity will decrease rapidly. After 15 minutes practically all activity will be gone.
At 37°C the enzyme activity will decrease more moderately and approximately 2 hours will be needed for a nearly complete inactivation.
Lower temperature ranges will not have a significant impact on the irreversible enzyme activity, except in the highest pH values between 10-11.   

The enzyme requires 1-2 mM Mg2+ of Mg2+ as a co-factor. In the presence of complexing agents such as phosphate and EDTA the concentration of Mg2+ needs to be increased to a maximum of 30 mM. 

No, the NuCLEANase^® product formulation does not contain prior added Mg2+ ions, and they need to be added accordingly.  

NuCLEANase^® is produced with our proprietary expression system, which has been engineered for low proteolytic activity. Nevertheless, like other food grade enzymes we cannot guarantee the absence of proteolytic activity. In case you do have concerns about specific proteases we advise to test this specifically.  

To our understanding, the submission of a food enzyme dossier for the nuclease is not required for its use in the manufacturing of other food enzymes used as processing aids. However, c-LEcta will submit a food enzyme dossier to EC (EFSA) to cover other possible applications of the nuclease in food manufacturing in Q4 of 2024.  

Yes c-LEcta has already submitted a GRAS dossier and recently also received a “no question letter” from the FDA. The listing of the GRAS Dossier for NuCLEANase^® is expected soon.   

Regulatory submissions to the national authorities in Denmark in France are in preparation and will be submitted shortly after the submission to EC.  

No. NuCLEANase^® is not GMO, it only derives from a GMM (genetically modified microorganism), but the final product is free of the production strain.