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Fc Effector Bioassays for Rapid and Quantitative Measurement of ADCC and ADCP Mechanisms of Action
EP25817
Fc Effector Bioassays for Rapid and Quantitative Measurement of ADCC and ADCP Mechanisms of Action
Submitted on 25 May 2017

Zhi-jie Jey Cheng, Rich Moravec, Aileen Paguio, Denise Garvin, Frank Fan, and Mei Cong
Promega Corporation, 2800 Woods Hollow Rd, Madison, WI 53711, USA
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Poster Abstract
Drug developers and regulatory authorities recognize antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP) as important mechanisms of action (MOA) of therapeutic antibodies. Traditional ADCC and ADCP bioassays use primary cells, which are labor intensive and highly variable. Less variable, easy-to-use and consistent analysis of these important MOA is needed in drug development programs.

To meet this need, we have developed a suite of functional cell-based Fc Effector reporter bioassays for the following receptors:

• Human FcgRIIIa (V158 and F158 variants)
• Human FcgRIIa (H131 and R131 variants)
• Human FcgRI
• Mouse FcgRIV* & FcgRIII*

Each bioassay is provided in “thaw-and-use” format for a rapid and convenient workflow and further reduction in assay variability. In qualification studies according to ICH guidelines, the bioassays show specificity, accuracy, precision, and linearity enabling their use in antibody screening, characterization, stability and potency studies.
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