The validation of HCP ELISA kits (Host Cell Protein) requires 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 an essential step in the validation of HCP quantification methods.
Materials to provide
Samples.
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Typical deliverables
Validation of anti-HCP antibodies using Western Blot.
Study following the specifications validated with the Expert.
Quality control.
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