Host Cell Protein (HCP) Antibody Coverage Analysis Service

HCP antibody coverage refers to the proportion of specific host cell proteins (HCPs) detected by antibodies during pharmaceutical production. HCPs are protein impurities that inevitably remain in the final product during the production of recombinant proteins or monoclonal antibodies using host cells (such as E. coli, mammalian cells, etc.). These HCPs may affect the safety and efficacy of the drug, and therefore must be removed or reduced to acceptable levels through specific purification steps.

 

HCP antibody coverage analysis is based on the principle of antigen-antibody specific binding, by combining the HCPs in the sample with specific HCP antibodies, and then measuring the amount of the complex using other methods such as ELISA, 2D-DIGE, etc. By comparing with known concentrations of standards, the content of HCPs in the sample is determined. This process helps us understand how many different types of HCPs are recognized and detected by the antibodies, thereby evaluating the coverage of these antibodies.

 



Razzazi-Fazeli, E. et al. Aflatoxins - Biochemistry and Molecular Biology. 2011.

Figure 1. HCP Antibody Coverage Analysis Based on 2D-DIGE

 

With the increasing scale and complexity of biopharmaceutical production, HCP antibody coverage analysis has become a key step in the quality control of biopharmaceutical products. Moreover, by assessing the purity and quality consistency of the product, this method has broad application value in the biopharmaceutical industry. The company has established four HCP antibody coverage analysis technology platforms combining regulations and practical applications, including 2D-WB, 2D-DIGE, AAE-2D, and AAE-nanoLC-MS/MS, to ensure the accuracy of HCP antibody validity analysis and meet various research needs. Free project evaluation, welcome to learn more details!

 

Deliverables

In the technical report, MtoZ Biolabs will provide you with detailed technical information, including:

1. Experimental Procedures

2. Relevant experimental Parameters

3. Detailed Information on HCP Antibody Coverage Analysis

4. Relevant Images

5. Raw Data

• • 2D-DIGE Antibody Coverage Analysis Service

  Two-dimensional fluorescence difference gel electrophoresis (2D-DIGE) is a proteomic technique for qualitatively and quantitatively comparing protein expression changes between different samples, such as pathological versus healthy tissues. This technique is crucial in the manufacturing of biological products, particularly during the host cell proteins (HCP) antibody coverage analysis, which is used to detect the sensitivity and specificity of HCPs.

• • AAE-nanoLC-MS/MS Antibody Coverage Analysis Service

  In the research and development and production of antibody drugs, Host Cell Protein (HCP) antibody coverage analysis is a key technology for ensuring drug quality and biological activity. Affinity Antibody Extraction (AAE) combined with nanoparticle liquid chromatography-tandem mass spectrometry (nanoLC-MS/MS) provides a powerful means for HCP antibody coverage analysis.

• • AAE-2D Antibody Coverage Analysis Service

  During the biopharmaceutical manufacturing process, the residue of Host Cell Proteins (HCPs) is an unavoidable quality control issue. These residual proteins may affect the safety, stability, and biological activity of the drug. Therefore, precise and comprehensive analysis of HCPs is crucial. Affinity Antibody Extraction-Two Dimensional electrophoresis (AAE-2D) is a technique primarily used for the efficient detection and analysis of proteins.