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BioTechnologia
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1/2014
vol. 95
 
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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
DOI: https://doi.org/10.5114/bta.2014.46409
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


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