Biological Activity Characterization

Jerrycret6808 Jan, 2024Technology

About Biological Activity Characterization Program In addition to physicochemical properties, biological activity characterization is an indispensable part of the biosimilars quality evaluation system. Biological activity characterization is the determination of the content and titer of active ingredients of antibody drugs, which is an important quality control index to ensure the effectiveness of antibody drugs, so it is necessary to establish a complete system for characterization. In general, it includes biological activity assays and binding activity assays. Commonly biological activity assays include: ADCC, CDC, inhibition of cell proliferation, cytotoxicity, cytokine secretion capacity, internalization, etc.