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.  

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 is influenced by process specific factors, such as the concentration of the substrate and the activity of the enzyme under the given process conditions. Like other enzymes NuCLEANase^® activity is impacted by factors such as the temperature, pH and the concentration of salts and if possible, you may be willing to optimize these based on your process. Further, you can lower the enzyme concentration by increasing the digestion time. 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 there is no need to remove NuCLEANase^® from the final product because of this reason.  

There is no strict regulatory need to remove NuCLEANase^® from your final food product (See also 2.5). Further, in most cases Nucleanase^® will be used at an early stage in the manufacturing process and the enzyme will be partially removed by the subsequent downstream process steps such as tangential flow filtration.   

If irreversible enzyme removal is desired, the following process steps and conditions can be recommended:   

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