MtoZ Biolabs Non-Specific Nuclease ELISA Kits: High-Sensitivity, High-Specificity Assays for Effective Monitoring of Residual Nuclease Activity in Biologics, Supporting Drug Stability and Safety
In biopharmaceutical manufacturing, non-specific nucleases are frequently introduced during steps such as cell lysis or nucleic acid removal. Residual enzymatic activity can degrade therapeutic nucleic acid products or compromise overall product stability, making these enzymes critical process-related impurities that must be tightly controlled. The Non-Specific Nuclease ELISA Kits from MtoZ Biolabs provide a comprehensive solution for residual nuclease monitoring. Our workflow spans highly sensitive activity assessment through streamlined sample preparation, supporting confident release decisions and alignment with stringent regulatory expectations.
Advantages
1. Ultra-High Sensitivity
Built on a plate-based ELISA format, the Non-Specific Nuclease ELISA Kits from MtoZ Biolabs achieve substantially greater sensitivity than conventional agarose gel electrophoresis, enabling detection of trace levels of residual enzymatic activity.
2. Rapid and Homogeneous Workflow
Most kit formats follow a simple add-incubate-read workflow, eliminating labor-intensive electrophoresis or transfer steps. This streamlined design makes the Non-Specific Nuclease ELISA Kits ideal for high-throughput screening and accelerated release timelines.
3. Excellent Specificity
The assay demonstrates minimal cross-reactivity with common host cell proteins from expression systems such as E.coli, CHO, and Sf9. No detectable cross-reactivity has been observed with Hansenula polymorpha host proteins, RNases, or bovine serum albumin, ensuring accurate and reliable results.
4. Regulatory Alignment
The method framework of the Non-Specific Nuclease ELISA Kits is designed to support impurity activity testing expectations described in guidelines such as ICH Q6B. Method validation support is available to facilitate compliant submissions and audits.
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.
