Milton, Mark, Dodge, Robert and Potthoff, Bernd (2022) 2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness. Bioanalysis.

Abstract

No Abstract.
Gene Therapy, Cell Therapy and Vaccines (9 Topics)
1. TAb/NAb & Anti-Viral Vector Antibody Companion Diagnostic Assays
2. Viral Vector Shedding Assays
3. Viral Vector Gene Therapy Immunogenicity & Pre-Existing Immunity
4. CRISPR/Cas9 Immunogenicity & Bioanalytical Challenges
5. CAR-T Immunogenicity & Cellular Kinetics
6. qPCR/ddPCR Assay Performance
7. Analyte Stability in Vaccine Serology Assays
8. Vaccine Critical Reagent Management and Bridging
9. Vaccine Bioanalytical Assays & Immune Monitoring

Immunogenicity of Biotherapeutics (8 Topics)
1. NAb Assays – Drug and Target Interference
2. ADA Cut Points – Appropriateness and False Positive Rates
3. Circulating Immune Complexes – ADA/Drug Complexes
4. ADA Assay Comparability
5. Integrated Summary of Immunogenicity Harmonization
6. China NMPA Immunogenicity Guidance
7. Multi-Domain Biotherapeutics & Bispecific Antibody Immunogenicity
8. Biosimilar ADA Assay Validation & Harmonization

Item Type:	Article
Date Deposited:	05 Jul 2022 00:45
Last Modified:	05 Jul 2022 00:45
URI:	https://oak.novartis.com/id/eprint/46981