Presentation Description: Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving filing queries. A neutralizing antibody testing and reporting team has formed to address the gaps in testing and reporting harmonization for plate and cell-based neutralizing antibody assays including new technologies and modalities such as cell and gene therapies. This rapid-fire will cover testing and reporting strategies for the following assessments: 1) robustness; 2) selection of the negative control pool; 3) selection of the positive control, reagent characterization and stability; 4) cut point determination; 5) assay sensitivity, and low positive control selection; 6) specificity, including drug and target tolerance; 7) assay selectivity to matrix components; 8) domain specificity for multi-domain therapeutics; 9) and novel approaches used to support the growing field of cell and gene therapies.
Upon completion, participant will be able to better understand the approach used for validation of cell-based neutralization antibody assays.
Upon completion, participant will be able to conduct validations of cell-based neutralizing antibody assays, including new technologies and modalities such as cell and gene therapies, in line with regulatory expectations.
Up completion, participant will be able to understand and conduct the necessary development and validation experiments that are used by industry scientists to facilitate filings to health authorities.