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

• Autorzy: RANCÉS BLANCO -SANTANA , MERCEDES CEDEŃO-ARIAS , ZULIA GARCÍA-PÉREZ , DAYANA COLUMBIÉ-GILBERT , ALEJANDRO PORTILLO-VAQUER , ENRIQUE RENGIFO-CALZADO
• Języki publikacji: EN

Abstrakty

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.

Słowa kluczowe

EN

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

• Czasopismo: BioTechnologia
• Rocznik: 2014
• Tom: 95
• Numer: 1
• Strony: 17-26

Daty

wydano

2014

Twórcy

autor

RANCÉS BLANCO -SANTANA

autor

MERCEDES CEDEŃO-ARIAS

autor

ZULIA GARCÍA-PÉREZ

autor

DAYANA COLUMBIÉ-GILBERT

autor

ALEJANDRO PORTILLO-VAQUER

autor

ENRIQUE RENGIFO-CALZADO

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• Typ dokumentu: paper