The Kanamycin ELISA Kits from MtoZ Biolabs provide a high-sensitivity, high-specificity analytical solution based on the indirect competitive ELISA principle. The kits enable precise monitoring of kanamycin residues in plasmid DNA raw materials used for gene and cell therapy, as well as in a wide range of other biologic products, helping safeguard the clinical safety of the final product.
Product Overview
Kanamycin is widely used as a selection marker during the cultivation of engineered bacteria harboring antibiotic-resistance plasmids to ensure stable replication of recombinant constructs. However, in the manufacture of final products, such as plasmid DNA for gene therapy, viral vectors, or downstream cell therapy materials, even trace levels of kanamycin may trigger allergic reactions or introduce other potential risks to patients. As a result, strict monitoring and accurate quantification are essential. Conventional microbiological or physicochemical approaches face substantial limitations in this application scenario:
1. Insufficient Sensitivity And Quantitative Capability
Microbial inhibition zone assays provide limited sensitivity and are typically qualitative or semi-quantitative. They are unable to support precise measurement of trace residues at the ng/mL level, making it difficult to accurately evaluate process clearance efficiency and product risk.
2. Severe Matrix Interference
Samples such as plasmid DNA preparations or cell lysates contain complex components, including high concentrations of nucleic acids, proteins, salts, and detergents. These factors can significantly interfere with activity-based or structure-generic detection methods, potentially leading to false-positive or false-negative results.
3. Limited Specificity And Susceptibility To Analog Interference
Aminoglycoside antibiotics share similar chemical structures. Non-targeted detection strategies may fail to effectively differentiate kanamycin from related compounds such as neomycin or gentamicin, thereby compromising the accuracy of residue risk assessment.
4. Stringent Regulatory Expectations And Burdensome In-House Validation
For advanced therapies including gene and cell therapy products, regulatory authorities impose rigorous requirements on the sensitivity, specificity, and validation completeness of impurity testing methods. Establishing in-house assays often demands substantial resources for systematic validation, resulting in extended timelines and increased operational burden.
Advantages
✅ High-Sensitivity Competitive ELISA Principle For Precise Quantification
The Kanamycin ELISA Kits from MtoZ Biolabs employ an indirect competitive ELISA format. Microplates are pre-coated with kanamycin-conjugated antigen, which competes with free kanamycin in the sample for a limited amount of specific anti-kanamycin monoclonal antibody. Using a TMB chromogenic system, absorbance is measured at 450 nm, with signal intensity inversely correlated with kanamycin concentration. This approach delivers outstanding sensitivity, with a lower limit of quantification as low as 0.5 ng/mL, enabling accurate measurement of ultra-trace residues.
✅ Exceptional Specificity With Clear Differentiation From Structural Analogs
High-specificity monoclonal antibodies are used, demonstrating extremely low cross-reactivity with structurally related aminoglycosides such as neomycin or amikacin. This design ensures that results accurately represent the true level of the target analyte and minimizes the risk of misinterpretation.
✅ Verified Suitability For Plasmid DNA Raw Materials
During development and validation, particular attention was given to the complex matrices associated with plasmid DNA used in cell and gene therapy applications. Reliable analytical performance has therefore been confirmed for this critical use scenario. After receiving the kit, users can establish the method rapidly through streamlined suitability verification before proceeding to routine sample testing and reporting.
✅ Comprehensive Validation Supporting Regulatory Compliance
Kit manufacturing and quality control are performed under a strict quality management framework. Performance characteristics have been validated in accordance with the expectations of major regulatory guidelines, including those outlined in the Chinese Pharmacopoeia and the USP. Parameters evaluated include specificity, sensitivity, precision, accuracy, and robustness, providing compliant and reliable data packages to facilitate regulatory submissions.
✅ Clear Workflow Compatible With Automation Platforms
A standardized operating procedure is provided to simplify implementation. The workflow can also be readily adapted to mainstream fully automated ELISA systems, enabling high-throughput, standardized testing while reducing manual variability and significantly improving laboratory efficiency and result consistency.
✅ Flexible Support For Expanded Applications
Although optimized for plasmid DNA materials, the method is also applicable to screening kanamycin residues in other biologics, such as recombinant proteins and vaccines. For these sample types, preliminary suitability testing is recommended to evaluate and mitigate potential matrix-specific interference.
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.
