Host Cell Protein ELISA Kits

MtoZ Biolabs Host Cell Protein ELISA Kits: A High-Sensitivity, One-Step Enzyme-Linked Immunosorbent Assay-Based Solution for Reliable Quantitative Detection of Residual Host Cell Proteins in Biologics Process Development and Product Release

Residual host cell proteins are critical process-related impurities that can impact the safety and immunogenicity of biologics. MtoZ Biolabs’ Host Cell Protein ELISA Kits are built upon a thoroughly validated one-step sandwich ELISA platform and are applicable to a wide range of commonly used host cell systems. The assay enables highly sensitive and highly specific quantitative measurement of residual host cell proteins, supporting comprehensive quality control throughout process optimization, in-process intermediate monitoring, and final product release, thereby ensuring compliance with regulatory requirements.

Advantages

1. Standardization and High Reproducibility

MtoZ Biolabs Host Cell Protein ELISA Kits provide ready-to-use, pre-coated assay plates together with optimized reagents, enabling a highly standardized assay workflow. This design significantly minimizes operational variability and ensures robust reproducibility across different batches and laboratories, thereby supporting assay transferability and long-term quality control applications.

2. High Sensitivity and Broad Dynamic Range

High-affinity matched antibody pairs are utilized, achieving detection sensitivity in the ng/mL to pg/mL range. The assay exhibits a broad dynamic range spanning 3–4 orders of magnitude, allowing direct analysis of diverse process-related samples without the need for prior concentration or dilution.

3. Broad Coverage of Host Cell Types

To address diverse production platforms, a comprehensive panel of pre-validated kits is available, including those targeting E. coli expression systems, HEK293, MDCK, Vero cells, and Pichia pastoris. This ensures effective coverage of the corresponding host cell protein (HCP) pools for each host system.

4. Excellent Assay Stability

All kit components are subjected to rigorous stability evaluation to ensure consistent performance throughout the designated shelf life. This reliability supports long-term and continuous process monitoring as well as routine product release testing.

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.