Validation of anti-HCP antibody
The validation of HCP ELISA kits (Host Cell Protein) requires a validation of the coating of the anti-HCP antibodies of the kit on the HCPs of the DS production process. The 2D differential in blot electrophoresis (2D-DIBE) technique is the technique of choice for this validation. Indeed, it combines a high resolution of the spots by large gels (20 x 23 cm) with the visualization of HCP and anti-HCP antibodies on the same membrane by immunodetection via a fluorescent tag.
This test is considered as an essential step in the validation of HCP quantification methods.
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