Assays to Evaluate Fragment Crystallizable (Fc)-Mediated Effector Function

November 1, 2019
USP

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This webcast will focus on industry best practices to develop and validate cell-based and non-cell-based formats for measuring Fc-mediated effector function activity including advantages, disadvantages, and points to consider for each assay format.. Live: Friday, Nov. 1, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET On demand available after airing until Nov. 1, 2020 Register free

Register Free: http://www.biopharminternational.com/bp_w/assays

Event Overview:
Fc effector function activities are mediated via interaction of the fragment antigen binding (Fab) domain of a therapeutic monoclonal antibody with the target antigen, and the interaction of the Fc domain with complement or various Fc gamma receptors (FcγR) expressed on cells of hematopoietic origin (e.g., natural killer, macrophage, dendritic, monocyte, and neutrophil). The different Fc-mediated effector function activities may include antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, antibody-dependent cellular phagocytosis, and Fc-dependent apoptosis.

This webcast will describe a new, informational USP general chapter <1108> that is intended to provide users with practical guidance regarding the selection, development, and validation of Fc function assays, including the measurement of low-affinity interactions observed FcγRs and the impact of glycosylation on antibody effector function.

The chapter details in-vitro assays that assess complex Fc domain interactions critical to the biological characterization of Fc-containing therapeutics. Best practices to develop and validate cell-based and non-cell-based formats for measuring these interactions are provided, as well as advantages, disadvantages, and points to consider for each assay format.

Key Learning Objectives:

  • Learn about the different Fc-mediated effector function activities

  • Review the various assay types, formats and technologies used to assess Fc-mediated effector function

  • Gain an understanding of the practical aspects of selecting, developing, and validating assays to assess Fc-mediated effector function

Speaker: Max Tejada, Senior Director, Bioassay Impurities and Quality BioPharmaceuticals Development, BioPharmaceuticals R&D, AstraZeneca

Time and Date: Friday, Nov. 1, 2019 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET

On demand available after airing until Nov. 1, 2020

Sponsor: USP

Register Free: http://www.biopharminternational.com/bp_w/assays