Qualification of HCP quality kits by ELISA
During the production process, contamination by host cell proteins (HCP) is nearly inevitable. Their presence can impact product efficiency (fragmentation or modification of the DS) but...
Bioprocess Quality control
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...
Developement of process-specific HCP ELISA
The development of a process-specific HCP ELISA HCP is recommended either, if no generic kit is suitable for bio-production, or for bioprocesses in advanced clinical phases. The advantage...
Development of antibodies specific anti-HCP
Obtaining anti-HCP antibodies is the critical step in the development of a specific process or platform ELISA. Indeed, it is advisable to obtain an antibody recognition recovery of at least...
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