Strategies for Nonclinical ADA Assessment - The presentation will focus on:
Current practices within EBF including survey data
Where can leaner and minimal approaches be used?
Decision tree
Cut point setting for nonclinical ADA
Sensitivity and Drug Tolerance requirements
Other validation parameters
Recommendations for sample analysis
Objective:
The 2019 FDA guidance - “immunogenicity testing of therapeutic protein products” has more detail on NAb assays, however there are areas that are open to interpretation.
This may be intentional by the agency to allow flexibility and sound scientific judgement depending on the assay format.
EBF NAb team (14 companies with NAb assay experts) started a discussion group: “Current practices within the EBF community and regulatory experience for using alternatives and competitive LBA (CLBA) versus cell-based assay (CBA)”.
