The presence of host cell proteins (HCPs) in biopharmaceutical products that arise from cell cultures is a widespread and pervasive problem. HCPs are fashioned from the very same host cells that are used to create the biopharmaceutical product and can be found in the final product at alarmingly low levels. Nevertheless, even these low levels of HCPs can significantly compromise the safety and effectiveness of the biopharmaceutical product. Thus, closely tracking and controlling the HCP levels during the development and production phases of biopharmaceuticals is of paramount importance.
Our HCP Antibody Coverage Analysis Services
Our HCP Antibody Coverage Analysis service uses high resolution large format 2D Western Blot, which can to be accurate, reproducible, and capable of detecting a wide range of HCPs.
Our services include sample preparation, electrophoresis, transfer, blocking, and detection. We work closely with our clients to develop customized protocols that meet their specific needs and requirements. We use a variety of detection methods, including chemiluminescence and fluorescence, to achieve the highest sensitivity and specificity.
Technology Advantage
Our avant-garde HCP antibody coverage analysis services, executed via the 2D Western blot methodology, provide an array of benefits over conventional Western blotting techniques.
Detect a broad range of HCPs in intricate samples: the two-dimensional electrophoresis technique implemented in our service separates the proteins grounded on their isoelectric point and molecular weight. This enables the identification of proteins that might be ignored by other methods, enhancing the sensitivity and efficacy of the analysis.
High precision and accuracy: by utilizing a blend of polyclonal and monoclonal antibodies, we are proficient in identifying a wide range of HCPs with remarkable accuracy, which in turn reduces the risk of false positives and guarantees that our clients receive dependable data, essential for drug development and production.
Great level of reproducibility: our workflows and protocols have been meticulously optimized to ensure the consistency and reliability of our results, irrespective of the sample type or origin.
Workflow
Our HCP Antibody Coverage Analysis by 2D Western Blot service follows a highly efficient and accurate workflow that has been optimized for maximum effectiveness.
Our well-established workflow includes several key steps that ensure the highest quality results are achieved:
Sample preparation, which involves a complex and intricate process that removes any interfering agents from the sample while simultaneously reducing the complexity of the sample matrix to ensure accurate results. Two-dimensional electrophoresis, which is a highly sophisticated and advanced technique that separates the sample by its isoelectric point and molecular weight. This enables us to identify and quantify even the most complex proteins that may be missed by other methods.
Western blotting, which involves the transfer of the proteins onto a specialized membrane, where they are probed with a highly specific combination of polyclonal and monoclonal antibodies. This ensures the highest level of sensitivity and specificity, which reduces the risk of false positives and guarantees reliable results.
Image analysis, which is a highly complex and intricate process that involves scanning the membrane with a specialized scanner and using advanced software to analyze the data. This enables us to identify and quantify the HCPs with the highest degree of accuracy and reproducibility possible.
Method Comparison
ELISA | 2D Western blot | 2D-DIBE | |
HCP detection | ✓ | ✓ | ✓ |
HCP coverage evaluation | - | ✓ | ✓ |
Rapid turnaround | ✓ | - | - |
Gel staining | - | Coomassie, fluorescent, silver | Not needed |
Immunodetection method | Chromogenic, fluorescent, chemiluminescent | Chromogenic, fluorescent, chemiluminescent | Fluorescent |
PTM detection | - | ✓ | ✓ |
Total protein and target detection on the same membrane | - | - | ✓ |
WB and Gel alignment needed | - | ✓ | - |
Accuracy | +++ | ++ | +++ |