The Non-Specific Nuclease ELISA Kit from MtoZ Biolabs is a high-sensitivity and high-specificity assay based on a dual-antibody sandwich ELISA principle. The method requires no complicated pretreatment and enables rapid and accurate monitoring of residual non-specific nucleases in biologics, ensuring product quality and stability.
Product Overview
In biopharmaceutical manufacturing, non-specific nucleases are key process enzymes used for nucleic acid removal, viscosity reduction, and purification improvement. However, trace residual enzyme may degrade functional nucleic acids in the product or trigger unintended immune responses. Therefore, these enzymes are regarded as process-related impurities that must be strictly controlled. When conventional activity assays or general residual protein methods are applied, the following challenges are commonly encountered:
1. Extremely High Sensitivity Requirements
After downstream purification, nuclease residues are present at extremely low levels. Traditional approaches such as gel electrophoresis or colorimetric assays often lack sufficient sensitivity to meet quantitative requirements for trace proteins at the pg/mL level, resulting in insufficient monitoring at critical risk points.
2. Multiple Sources of Interference in Activity Measurements
Methods based on enzymatic activity, such as fluorescence substrates, are easily affected by pH, ionic strength, inhibitors, or cofactors within complex sample matrices. These interferences can compromise accuracy and cannot distinguish between active and inactive enzyme proteins.
3. Heavy Burden of Method Development and Validation
Establishing an in-house immunoassay requires substantial resources for antibody development, pair screening, and comprehensive performance validation. The process is time-consuming and costly, making it difficult to rapidly support process development or release needs.
4. Operational Complexity and Limited Automation
Multi-step pretreatment procedures or complicated activity measurements rely heavily on manual operations. Standardization and high-throughput implementation are difficult, making these approaches less suitable for routine quality control in large-scale manufacturing.
Advantages
✅ High Sensitivity and Specificity With Direct Protein Detection
The MtoZ Biolabs Non-Specific Nuclease ELISA Kit directly measures the nuclease protein itself rather than enzymatic activity. The assay provides a limit of detection as low as 73.6 pg/mL, enabling accurate quantification of trace residues and aligning with stringent quality expectations for biologics.
✅ Simple Operation With No Complex Pretreatment
Samples generally require no special processing. After determining an appropriate dilution ratio through a simple suitability verification, they can be loaded directly for analysis. The optimized workflow shortens the time from sampling to results.
✅ Stable and Reliable Performance, Ready to Use
All kit components undergo rigorous quality control and performance verification to ensure batch-to-batch consistency. Analytical parameters have been validated according to relevant pharmacopeial and regulatory expectations, allowing laboratories to put the assay into use following simplified suitability confirmation.
✅ Fully Compatible With Automation to Improve Efficiency
The workflow is designed with high-throughput requirements in mind and can be seamlessly integrated with automated ELISA systems. Automation from sample loading to plate reading significantly improves efficiency, reproducibility, and standardization.
Technical Support
1. Protocol Downloads
MtoZ Biolabs provides comprehensive experimental protocols and product manuals to help ensure smooth and reproducible workflows. For access to specific documents or detailed instructions, please contact our support team.
2. Customized Service Support
Our experienced scientists offer tailored technical assistance and customized solutions based on your specific research goals, helping you achieve optimal experimental outcomes.
3. FAQ and Expert Assistance
We provide responsive and professional technical support to address your questions efficiently. Our experts are ready to help you identify and resolve experimental challenges quickly and accurately.
