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Reportlinker Adds Immunogenicity to Biologics
Date:11/3/2010

2.8. Challenges with monoclonal antibodies and other biologic products

3. Interpretation of results 3.1. Selection of reference standards and controls 3.2. Determination of cut-points 3.3. How do you work out if your results are significant or not – are the detected neutralising antibodies relevant in vivo? 3.4. How do results correlate with efficacy? 3.5. How to generate positive controls 3.6. How to prepare a calibration serum for an ELISA 3.7. Quantification of results: mass units v. titres 3.8. Dealing with drug interference with antibodies

4. Validation of neutralising assays 4.1. What needs to be validated in each clinical phase including pre-clinical. 4.2. Ensuring detection of low affinity as well as high affinity antibodies

5. Characterisation of antigen/antibody response and isotype determination 5.1. What do the antibodies bind to? 5.2. How do you identify the isotype? 5.3. What are the benefits of this? 5.4. Secondary characterisation

6. Comments on US White paper and EU guidelines to date 6.1. Guidelines on presentation of data

6.2. Risk-based assessment

7. Case studies if possible 7.1. Challenges with monoclonal antibodies and other biologic products

Chapter 5 Evaluation of Immunogenicity for Preclinical and Clinical Investigations

Dr Ingrid Caras, Senior Director, Preclinical and Clinical Development Sciences, PDL BioPharma, Fremont, CA, USA 1. Introduction

2. Preclinical immunogenicity safety assessment 2.1. Other options for pre-clinical immunogenicity assessments

3. Pre-clinical studies in animals

4. Clinical immunogenicity issues 4.1. Immunogenicity risk assessment 4.2. Implication of immunogenicity for the clinical program 4.3. Significance of low level immune responses 4.4. Incorporation of assays into the clinical program 4.5. Phase 1 studies 4.6. Drug interference and study design 4.7. Endpoints 4.8. Validation 4.9. When and how often should samples b
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