Strategies for method comparison when changes in the immunogenicity method are needed within a clinical program
- 1 April 2020
- journal article
- review article
- Published by Future Science Ltd in Bioanalysis
- Vol. 12 (7), 431-443
- https://doi.org/10.4155/bio-2019-0300
Abstract
Aim: To present the reader with different approaches used to compare immunogenicity methods when changes are needed during a clinical program. Results: 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. Conclusion: When data pooling across methods is needed, it is important to define the limits of comparability.Keywords
This publication has 7 references indexed in Scilit:
- Effective presentation of immunogenicity risk assessments and related data in regulatory dossiersBioanalysis, 2019
- Comparison of immunogenicity test methods used in clinical studies of infliximab and its biosimilar (CT-P13)Expert Review of Clinical Immunology, 2015
- Strategies to compare clinical antitherapeutic antibody data when changing assay platforms: a case studyBioanalysis, 2015
- The quintessence of immunogenicity reporting for biotherapeuticsNature Biotechnology, 2015
- Clinical immunogenicity specificity assessments: A platform evaluationJournal of Pharmaceutical and Biomedical Analysis, 2011
- Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology productsJournal of Immunological Methods, 2008
- Comparing ELISA and Surface Plasmon Resonance for Assessing Clinical Immunogenicity of PanitumumabThe Journal of Immunology, 2007