Course Description: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.
The live version of this recording took place on November 1, 2019.Recording includes English subtitles.
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
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
Who should participate:
- Lab managers
- Principal scientists
- R&D
- Analytical
- Scientists at CDMO’s and contract analytical labs
- Regulatory experts working in the field of biologics
- QA/QC scientists at biopharmaceutical companies
- Bioassay statisticians