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Fc Effector Bioassays for Rapid and Quantitative Measurement of ADCC and ADCP Mechanisms of Action
EP25817
Poster Title: Fc Effector Bioassays for Rapid and Quantitative Measurement of ADCC and ADCP Mechanisms of Action
Submitted on 25 May 2017
Author(s): Zhi-jie Jey Cheng, Rich Moravec, Aileen Paguio, Denise Garvin, Frank Fan, and Mei Cong
Affiliations: Promega Corporation, 2800 Woods Hollow Rd, Madison, WI 53711, USA
Poster Views: 1,661
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Poster Information
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.
Summary: Drug developers are rapidly adopting Fc effector function reporter-based bioassays to measure antibody Fc functions such as ADCC and ADCP activity during the development of therapeutic antibodies. Here we show application of a suite of FcgR Reporter Bioassays to elucidate and characterize antibody MOA. Report abuse »
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