Immunogenicity – How to successfully validate your assay
Immunogenicity is the property of a substance to elicit a humoral and/or cell-mediated immune response in organisms. Immune responses to a therapeutic protein product, caused by the formation of anti-drug antibodies (ADA), can lead to different negative effects ranging from loss of efficacy of the drug product to the observation of undesired side effects. In some cases, this can also generate serious adverse events. The development and validation of appropriate assays to assess unwanted immunogenicity is therefore a key component of drug marketing authorization applications and represents nowadays a big challenge due to the complexity of biological drug products, the effect of diverse biological matrices and regulatory requirements.
The live webinar “Immunogenicity - how to successfully validate your assay” will provide an overview of the performance characteristics that are important for the validation of ADA Immunoassays (according to regulatory authorities e.g. FDA/EMA) including:
- Screening cut point and specificity cut point
- Determination of suitable quality controls
- Sensitivity
- Drug interference (Drug tolerance limit)
- Selectivity -> Matrix interference
- Assay precision
- Robustness
- Stability
In addition, the following questions will be addressed during the webinar:
- Considerations for an in-study cut point
- Which parameters should be re-assessed in case of a lot of change of one or more critical reagents
- Which validation parameters are required for a neutralizing antibody assay
- Further characterization of ADAs (e.g. isotype, titration)
Who should attend: BioPharmaceutical scientists, research and development specialists, laboratory managers
About the speaker: Dr. Maximilian Schmid, Senior Study Director, Eurofins BioPharma Product Testing Munich GmbH
The webinar is now accessible on-demand
Webinar language: ENGLISH
Watch webinar on-demand
