| 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
|
|
