The MtoZ Biolabs Human Serum Albumin (HSA) ELISA Kit (ELISA) is a high-sensitivity, high-specificity quantitative assay for the detection of residual BSA during biopharmaceutical manufacturing processes, providing a critical quality control tool to support process safety and product release.
Product Overview
Bovine serum albumin (BSA) is widely used in biopharmaceutical research and manufacturing: as a blocking agent in immunoassays such as ELISA and Western blotting; as a carrier protein to enhance antigen immunogenicity; as a stabilizer in enzymatic reaction systems; or as a direct supplement in cell culture media. However, as a process-related additive, residual BSA may introduce potential immunogenicity risks and is therefore considered a critical quality attribute in biologics quality control. Accurate detection of trace-level BSA residues presents several challenges:
1. Extremely High Sensitivity Requirements
After purification, residual BSA levels are typically very low. Conventional protein quantification methods (e.g., the Bradford assay) lack sufficient sensitivity to meet ng/mL-level detection requirements, creating a risk of false negatives.
2. Complex Sample Matrices and Significant Interference
Test samples (such as cell culture supernatants, purification intermediates, or drug substance) often contain high concentrations of product proteins, other media components, or buffer salts. These factors can cause matrix effects or cross-reactivity, compromising assay specificity and accuracy.
3. Lack of Standardized Method Validation
Laboratory-developed assays often lack systematic performance validation. Key parameters, including precision, accuracy, linearity, and robustness, may not be fully evaluated, making it difficult to meet the stringent requirements for regulatory submissions and product release.
4. Labor-Intensive Workflows and Limited Throughput
Traditional multi-step ELISA procedures are time-consuming and heavily dependent on manual operations, limiting their suitability for rapid feedback during process development or high-throughput testing in quality control settings.
Advantages
1. High Sensitivity to Meet Stringent Quality Control Requirements
Based on a sandwich ELISA format using high-affinity paired antibodies, the MtoZ Biolabs Human Serum Albumin (HSA) ELISA Kit (ELISA) delivers outstanding analytical sensitivity, with a lower limit of quantification as low as 1 ng/mL. This performance enables reliable detection of trace levels of residual BSA in biopharmaceutical products, meeting practical testing needs from process development through final product release.
2. Excellent Specificity and Strong Resistance to Interference
The antibodies used in the kit are rigorously screened and validated to ensure high specificity for BSA. Common commercial sources of BSA have been extensively tested and evaluated, all showing robust recognition performance. This high selectivity effectively minimizes interference from other complex sample components, ensuring accurate and reliable results.
3. Optimized Workflow for Simple and Rapid Operation
The assay workflow has been thoroughly optimized to provide a streamlined procedure with reduced hands-on time. The complete process is fully compatible with automated platforms, such as automated ELISA analyzers, enabling high-throughput and standardized testing while significantly improving laboratory efficiency and reducing operator-dependent variability.
4. Comprehensive Validation and Stable, Controlled Quality
The kit has undergone a full set of performance validations in accordance with relevant regulatory guidelines, including the Chinese Pharmacopoeia and USP, covering specificity, sensitivity, precision, accuracy, linearity, and range. With stable quality and excellent lot-to-lot consistency, it provides reliable and compliant data support for 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.
