REVIEW PAPER
Validation of a flow cytometry-based assay for monitoring
complement-dependent cytotoxicity of an anti-CD20
biosimilar candidate antibody
Publication date: 2014-10-23
BioTechnologia 2014;95(1):17-26
KEYWORDS
ABSTRACT
Appropriate validation of any bioassay to be used in the characterization of biological products is critical. In this
study, we report a validation study of a flow cytometry-based assay to measure the complement-dependent cytotoxicity
(CDC) of a biosimilar candidate monoclonal antibody (Mab) directed to CD20 antigen, as indicative of its
biological activity. The assay was validated by examining: assay robustness, specificity, repeatability and intermediate
precision. It demonstrated to be robust for all factors evaluated. It also showed a high level of specificity
and was found to be free of interference through the validation process. The degree of precision (Cvs < 7%) obtained
in this study was satisfactory. The presented work demonstrated that a flow cytometry-based cytotoxicity
assay is a suitable method in the lot to lot quality control monitoring of the culture supernatant and an active
pharmaceutical ingredient of 1B8 Mab.
study, we report a validation study of a flow cytometry-based assay to measure the complement-dependent cytotoxicity
(CDC) of a biosimilar candidate monoclonal antibody (Mab) directed to CD20 antigen, as indicative of its
biological activity. The assay was validated by examining: assay robustness, specificity, repeatability and intermediate
precision. It demonstrated to be robust for all factors evaluated. It also showed a high level of specificity
and was found to be free of interference through the validation process. The degree of precision (Cvs < 7%) obtained
in this study was satisfactory. The presented work demonstrated that a flow cytometry-based cytotoxicity
assay is a suitable method in the lot to lot quality control monitoring of the culture supernatant and an active
pharmaceutical ingredient of 1B8 Mab.
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| eISSN: | 2353-9461 |
| ISSN: | 0860-7796 |
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