MtoZ Biolabs' Streptococcus Protein G ELISA Kit is a high-sensitivity immunoassay kit designed for the quantitative detection of residual Protein G in biopharmaceutical products and process intermediates. It enables accurate measurement of leached Protein G in purified antibody preparations, column eluates, and formulation buffers. This kit is widely used in antibody manufacturing process monitoring, downstream purification quality control, and regulatory compliance testing.
Product Overview
Protein G is a streptococcal cell surface protein widely used as an affinity ligand for IgG purification. Ligand leaching during chromatography introduces trace Protein G into final products, posing several detection challenges:
1. Intrinsic IgG-Binding Activity
Protein G binds IgG Fc regions with high affinity, causing non-specific bridging and false signals in IgG-based immunoassays.
2. Extremely Low Residual Levels
Leached Protein G typically falls in the low ng/mL range, demanding ultra-high assay sensitivity.
3. High IgG Background
Final products contain mg/mL-level IgG, requiring detection of trace Protein G against a massive excess of its natural binding partner.
4. Multiple Leached Forms
Intact protein, fragments, and denatured variants each exhibit different immunoreactivity, complicating consistent quantification across process conditions.
5. Regulatory Requirements
Agencies mandate validated clearance testing for affinity ligand residuals, with stringent acceptance criteria for lot release and process validation.
Advantages
✅ Sensitivity
LOD reaches the low ng/mL level.
✅ Specificity
Antibodies are selected to specifically recognize Protein G epitopes independent of its IgG-binding domain, minimizing interference from high-concentration IgG matrices and ensuring accurate quantification of free and bound Protein G residuals.
✅ Precision
Intra-assay and inter-assay CVs are within acceptable limits.
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.
