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 also compromise patient safety.
The presence of HCP caused clinical phases to be stopped or put on hold (i.g. Genentech stopped its Lebrikizumab program because of the presence of PLBL2 associated with DS fragmentation and immunogenicity patients).
The control of HCP is now required by health authorities and the levels of HCP (for protein DS) must be less than 100 ppm.
The quantification of HCP is commonly done by ELISA (Enzyme-Linked Immunosorbent Assay). However, the validation of commercially available tests (called "generic") is essential.
First of all an extensive validation of the ELISA: LOD/LOD, spike recovery, dilution linearity ... with customer samples must be performed. The second step consists of validating the coverage of the kit antibodies against the customer's HCP.
Materials to provide
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Limit of detection (LOD).
Limit of quantification (LOQ).
Study following the specifications validated with the Expert.
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