The E.coli HCP (Expression Strains) ELISA Kit (One-Step ELISA) from MtoZ Biolabs is a high-performance, highly stable assay solution designed specifically for E.coli expression systems, enabling precise quantification of residual host cell proteins (HCPs) from engineered strains such as BL21 to support process safety and batch release testing for recombinant protein products.
Product Overview
During recombinant protein manufacturing in E.coli (e.g., BL21), residual host cell proteins (HCPs) are critical process-related impurities that may affect product purity and stability and potentially trigger undesired immunogenic responses. However, conventional or “universal” HCP detection methods often face practical challenges in this application:
1. Insufficient Coverage for E.coli-Specific HCP Profiles
Broad-spectrum HCP strategies may not adequately cover the complex, E.coli-derived HCP repertoire, resulting in reduced sensitivity for key residual proteins and an increased risk of undetected impurities.
2. Time-Consuming, Multi-Step Workflows
Traditional multi-step ELISAs or methods requiring complex sample preparation are labor-intensive and slow, making them poorly suited for rapid feedback during process development or high-throughput batch release testing.
3. High Validation Burden for In-House Methods
Lab-developed assays often require substantial resources for full performance qualification and standardization to meet pharmacopeial and regulatory expectations, leading to long timelines and operational complexity.
4. Limited Long-Term Robustness and Poor Automation Compatibility
Extensive manual handling can introduce variability, and some methods are not designed with automation in mind, reducing throughput and compromising long-term result consistency.
Advantages
✅ Highly Targeted Design With Strong Risk Coverage
The MtoZ Biolabs E.coli HCP (Expression Strains) ELISA Kit (One-Step ELISA) is optimized specifically for the HCP repertoire of BL21-derived expression strains. The antibody coverage has been thoroughly validated to deliver excellent sensitivity and breadth for critical residual HCP components commonly encountered in process intermediates and bulk drug substance samples. It is particularly suitable for recombinant protein products such as interleukins (ILs), recombinant interferons (rhIFN), recombinant GM-CSF (rhGM-CSF), recombinant TNF (rhTNF), and growth factors including EGF/FGF/PDGF.
✅ Streamlined Workflow for Faster Turnaround
Built on an optimized one-step sandwich ELISA format, the assay is simplified to one sample addition step and one wash step. The entire procedure can be performed at room temperature without specialized equipment (e.g., incubators), significantly reducing assay time while improving ease of use and laboratory efficiency.
✅ Outstanding Sensitivity Aligned With Release Needs
The method provides high analytical sensitivity, with a lower limit of quantification (LLOQ) down to 1.5 ng/mL, enabling reliable detection of trace HCP residues and supporting practical sensitivity requirements for in-process monitoring and final product release.
✅ Consistent Performance With Controlled Quality
Manufacturing follows a rigorous quality management system, and each lot undergoes strict QC. In alignment with relevant pharmacopeial and regulatory guidance, the assay performance has been validated across a full set of key parameters, including precision, accuracy, specificity, linearity, and range, providing dependable data support.
✅ Automation-Ready Design With Simplified Validation
The E.coli HCP (Expression Strains) ELISA Kit (One-Step ELISA) is designed with automation in mind and integrates seamlessly with automated ELISA analyzers and other high-throughput platforms for standardized testing. For customer implementation, only a straightforward fitness-for-use (suitability) verification is typically required, enabling rapid method onboarding while substantially reducing validation workload and time cost.
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.
