Describe limitations of bridging assay design Describe alternative methods used today for ADA detection Offer insights into methodological differences and impact of statistical determination of ADA cut points Provide an alternative approach for assay configuration and cut point statistical computation
Learning Objectives:
To provide insight for the impact of assay design on statistical cut point determination for non-bridging assay designs.
To provide insight for the impact of assay design to aid interpretation of clinical immunogenicity results obtained from non-bridging assay designs
Implement improved alternative assay designs to support immunogenicity testing across a wide range of biotherapeutic constructs that are not well suited for testing by a conventional bridging assay
