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Reportlinker Adds Immunogenicity to Biologics

ute of administration 1.6. The influence of dose 1.7. Influence of immune status of patient

2. Clinical Consequences of an Immune Response 2.1. Examples of severe clinical consequences 2.2. Therapeutic proteins with reduced immunogenicity or no clinical consequences 2.3. Risk factors and the monitoring of potential immunogenicity

3. References

Chapter 3 Practical Approach to Assay Development and Validation

Meenu Wadhwa* and Robin Thorpe** * Section Leader, Cytokines and Growth Factor Section, Biotherapeutics Group ** Head, Biotherapeutics Group, National Institute for Biological Standards and Control, UK

1. Introduction

2. Strategy for immunogenicity assessment

3. Assays for detection of antibodies and their practical application 3.1. Screening assays 3.2. Technical challenges associated with screening assays 3.3. Antibody controls and reagents for antibody assays 3.4. Limits of detection, sensitivity, cut-points and other critical issues 3.5. Interpretation of results and data analysis 3.6. Guidance On Antibody Assays for Immununogenicity Assessment 3.7. Validation of assays 3.8. Impact of antibodies on clinical response

4. References

Chapter 4 Considerations for the Development and Validation of Assays for Neutralising Antibodies and Interpretation of Data

Dr Deborah Finco-Kent, Senior Scientist, Immunogenicity Assay Coordinator, Pfizer Inc., USA

1. Introduction 1.1. Impact of neutralising antibodies on clinical results: safety and efficacy 1.2. Significance of neutralising antibody assays for pre-clinical testing 1.3. When to determine neutralising activity

2. Design and development of neutralising assays 2.1. How to develop quickly and with minimum cost 2.2. Ligand-binding versus cell-based assays 2.3. Sensitivity required 2.4. Other assays 2.5. Factors affecting assay performance 2.6. How to deal with drug interference 2.7. Determination and detection of cut points

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