A high-performance, non-radioactive potency assay for measuring cytotoxicity: A full substitute of the chromium-release assay targeting the regulatory-compliance objective.

ABSTRACT: Standardized and biologically relevant potency assays are required by the regulatory authorities for the characterization and quality control of therapeutic antibodies. As critical mechanisms of action (MoA) of antibodies, the antibody-dependent cell-meditated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) must be characterized by appropriate potency assays. The current reference method for measuring cytotoxicity is the ⁵¹Cr-release method. However, radioactivity handling is difficult to implement in an industrial context because of environmental and operator protection constraints. Alternative non-radioactive methods suffer from poor validation performances and surrogate assays that measure FcγR-dependent functions do not comply with the regulatory requirement

SUBMITTER: Rossignol A 

PROVIDER: S-EPMC5384798 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature