Elements Description
Quality Manage process changes
Sensitivity of analytical methods to allow determination of changes to product (aggregation, glycosylation etc.)
Formulation and impact of changes
BioanalyticalAssay Assay format and assay platform
Sensitivity, drug tolerance, assay range
Positive controls  
Nonclinical/Clinical Sampling plan
Studies in clinical development plan to assess specific aspects of immunogenicity Safety monitoring assessment of immunogenicity on efficacy
Reporting/analysis plan  
Table 2: Plan for controlling immunogenicity.