Fatemeh Torkashvand
Pasteur Institute of Iran, Iran
Title: An in-vitro functional assessment of a biosimilar rituximab and its originator
Biography
Biography: Fatemeh Torkashvand
Abstract
This study described the functional characterization of a biosimilar rituximab and its originator. Functional characterization contained of a series of bioassays: Surface Plasmon Resonance (SPR) assays for Fc receptors binding analysis, Complement- Dependent Cytotoxicity (CDC) and Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) assays. With regard to binding of Fc to Fc gamma receptors mediates ADCC and CDC, complete affinity study of these receptors can increase the knowledge about the acceptable range of amount of these Critical Quality Attributes (CQAs). A widespread functional characterization package displayed that biosimilar rituximab has similar biological properties as originator rituximab; also the cell-based bioassays confirmed this.