Host Cell Residual Protein Assays are a critical component of biopharmaceutical quality control and directly influence drug safety and efficacy. Conventional detection approaches are limited in sensitivity, specificity, and throughput, making comprehensive coverage of low-abundance, high-risk residual proteins in complex samples challenging. MtoZ Biolabs provides a comprehensive HCP detection solution, ranging from high-sensitivity assay kits to high-specificity antibodies, supporting process development and batch release that meet regulatory requirements and helping achieve accurate, reliable, and efficient monitoring of residual proteins.
Products
1. Host Cell Protein ELISA Kits
Ready-to-use, high-sensitivity ELISA assay kits are available for multiple common host cell sources, including CHO, HEK293, and Escherichia coli. These kits are applicable to quantitative HCP analysis during process development, drug substance release, and final product release.
2. HCP Polyclonal Antibodies
For different host cell sources, thoroughly validated polyclonal antibodies with high specificity are available. These antibodies support multiple analytical platforms, such as Western Blot and immunohistochemistry, and are suitable for method development and supplementary verification.
3. High-Risk Protein Detection Kits
Specific detection solutions are available for host cell proteins with known immunogenicity or biological activity, supporting in-depth evaluation of product safety.
Lab Equipment at MtoZ Biolabs
1. Refrigerated Centrifuge
Low-temperature operation throughout the workflow effectively prevents protein degradation and preserves the integrity of protein complexes and modifications, ensuring the biological activity and authenticity of enriched samples.
2. Vortex Mixer
Efficient and gentle mixing improves the binding efficiency and consistency of immunoprecipitation or affinity enrichment, with simple operation and reduced processing time.
3. Vacuum Concentrator
A mild low-temperature concentration process avoids degradation of target peptides or loss of modifications. High processing throughput significantly improves the efficiency of mass spectrometry sample preparation.
4. pH Meter and Analytical Balance
These instruments are used for accurate preparation of pretreatment and digestion buffers, ensuring optimal reaction conditions.
Advantages
1. High Sensitivity and Wide Dynamic Range
Optimized antibody pairs and detection systems enable pg-mL level sensitivity, accommodating analytical requirements across different stages of process development.
2. High Specificity and Low Cross-Reactivity
Antibodies undergo rigorous screening and validation to ensure high-specificity recognition of target HCPs, significantly reducing the risk of false-positive signals.
3. Regulatory Compliance
Product design and validation support relevant guidelines from ICH, FDA, and EMA and are suitable for regulatory submission and quality control.
4. Flexible Platform Compatibility
Compatibility with multiple analytical platforms, including ELISA, Western Blot, and mass spectrometry, supports diverse experimental needs from initial screening to confirmatory analysis.
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.
