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1/2014
vol. 95 abstract:
Review paper
Validation of a flow cytometry-based assay for monitoring complement-dependent cytotoxicity of an anti-CD20 biosimilar candidate antibody
Rancés Blanco-Santana
,
Mercedes Cedeńo-Arias
,
Zulia Garcìa-Perez
,
Dayana Columbié-Gilbert
,
Alejandro Portillo-Vaquer
,
Enrique Rengifo-Calzado
BioTechnologia vol. 95(1) C pp. 17-26 C 2014
Online publish date: 2014/10/23
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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. keywords:
flow cytometry, complement-dependent cytotoxicity, validation study, therapeutic anti-CD20 Mab, Biosimilar |