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1 BioTechnologia

1 2014

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Validation of a flow cytometry-based assay for monitoring complement-dependent cytotoxicity of an anti-CD20 biosimilar candidate antibody

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BLANCO -SANTANA R. , CEDEŃO-ARIAS M. , GARCÍA-PÉREZ Z. , COLUMBIÉ-GILBERT D. , PORTILLO-VAQUER A. , RENGIFO-CALZADO E.

nr 1

17-26

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.