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

• Authors: RANCÉS BLANCO -SANTANA , MERCEDES CEDEŃO-ARIAS , ZULIA GARCÍA-PÉREZ , DAYANA COLUMBIÉ-GILBERT , ALEJANDRO PORTILLO-VAQUER , ENRIQUE RENGIFO-CALZADO
• Languages of publication: EN

Abstracts

EN

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

EN

Biosimilar; complement-dependent cytotoxicity; flow cytometry; therapeutic anti-CD20 Mab; validation study

Discipline

• MEDICINE: MEDICINE

• Publisher: Committee of Biotechnology, Polish Academy of Sciences
• Journal: BioTechnologia
• Year: 2014
• Volume: 95
• Issue: 1
• Pages: 17-26

Dates

published

2014

Contributors

author

RANCÉS BLANCO -SANTANA

author

MERCEDES CEDEŃO-ARIAS

author

ZULIA GARCÍA-PÉREZ

author

DAYANA COLUMBIÉ-GILBERT

author

ALEJANDRO PORTILLO-VAQUER

author

ENRIQUE RENGIFO-CALZADO

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• Document Type: paper