MtoZ Biolabs BSA & HSA ELISA Kits: High-Sensitivity and High-Specificity ELISA Detection of BSA and HSA Process Residuals in Biopharmaceutical Products
Bovine serum albumin (BSA) and human serum albumin (HSA) are critical process-related impurities that may be introduced during cell culture, purification, or formulation, and their residual levels can directly impact the immunogenicity and safety of biopharmaceutical products. MtoZ Biolabs' BSA & HSA ELISA Kits are built on robust and well-established enzyme-linked immunosorbent assay (ELISA) technology, delivering excellent sensitivity and specificity for rapid and accurate quantitative detection. These kits support end-to-end monitoring from upstream process development through final product release, helping ensure compliance with both domestic and international pharmacopeial and regulatory requirements.
Advantages
1. High Sensitivity and Quantitative Accuracy
MtoZ Biolabs' BSA & HSA ELISA Kits employ high-affinity, highly specific matched antibody pairs, achieving detection sensitivity at the ng/mL level. With a broad linear dynamic range of the standard curve, the kits enable accurate quantification of trace levels of BSA and HSA in complex samples, ensuring reliable detection of low-level residuals.
2. Stringent Specificity Assurance
All antibodies are rigorously validated to ensure high specificity toward the target proteins (BSA or HSA), effectively minimizing cross-reactivity with other proteins present in the sample matrix, such as product proteins or other serum-derived components. This design ensures the accuracy and reliability of the detection results.
3. Simple Workflow and High Throughput
The kits are supplied with pre-coated microplates and ready-to-use reagents, supporting either one-step or two-step ELISA workflows. The entire assay can be completed within a few hours, offering high throughput and making the kits well suited for large-scale screening and release testing of process samples.
4. Calibrated Standards and Quality Controls
Each kit includes precisely calibrated BSA or HSA standards, with optional BSA quality control samples available. These components provide a robust basis for intra-laboratory and inter-laboratory quality control, ensuring assay stability and data comparability across studies and testing sites.
5. Comprehensive Regulatory and Compliance Support
The assay design and performance parameters align with relevant guidelines from the USP and ICH. Method validation strategies and technical support can be provided to facilitate regulatory submissions and the establishment of compliant quality control systems.
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.
