Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program

To present the reader with different approaches used to compare immunogenicity methods when changes are needed during a clinical program. Five case studies are presented, in the first two case studies, the approach utilized a small sample size for the comparison. In the third case, all samples from...

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Bibliographic Details
Published in:Bioanalysis 2020-04, Vol.12 (7), p.431-443
Main Authors: Mora, Johanna R, White, Joleen T, Chilewski, Shannon D, Qu, Qiang, Stocker, Dennis, Luo, Linlin, Lavelle, Amy
Format: Article
Language:English
Subjects:
Antibodies
Biological products
Case studies
Corporate sponsorship
Datasets
Immunogenicity
Immunology
life-cycle management
limits of comparability
method comparison
method transfer
Methods
Multiple myeloma
Oncology
Patient safety
pooled immunogenicity
Proteins
Risk assessment
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Description
Summary:To present the reader with different approaches used to compare immunogenicity methods when changes are needed during a clinical program. Five case studies are presented, in the first two case studies, the approach utilized a small sample size for the comparison. In the third case, all samples from a study were analyzed by both methods. In the fourth case, the intended use of noncomparable assays in an integrated summary drove design of experiments to establish the expected limits of pooling data. In the fifth case, a selectivity approach was used as an alternate to use of incurred samples. When data pooling across methods is needed, it is important to define the limits of comparability.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2019-0300