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

ficacy

• Commercial implications

• Assay development and validation with special section on neutralising antibody assays

• NEW US White Papers

• Regulatory advice on working with the FDA and EMEA with NEW CHMP Guidelines

• Risk management strategy

• Risk minimisation and de-immunisation

This report is essential reading for anyone in the biotech, pharmaceutical and clinical outsourcing industries from corporate management through development and research to marketing and sales. It gives an authoritative, detailed and clear explanation of the issues surrounding immunogenicity and their implications for the market and for the biotech and pharmaceutical industries.

CONTENTS Chapter 1

Immunogenicity: Commercial Threat to Biotechnology-Derived Therapeutic Proteins?

Jo Pisani and Yann Bonduelle, Pharmaceutical Strategy Consultants, PricewaterhouseCoopers LLP, UK

1. Summary

2. Impact of Biological Products on the Global Pharmaceutical Market

3. Commercial Potential of Monoclonal Antibodies

4. Key Therapy Areas Likely To Be Impacted by Immunogenicity

5. Potentially Immunogenic Drug Types

6. Key Commercial Metrics

6.1 Key Metric: Risk

6.2 Key Metric: Cost

6.3 Key Metric: Time

6.4 Key Metric: Value

7. Impact of Immunogenicity on Product Profile and Physician's Choice of Treatment

8. Reported Immunogenicity of Major Biological Product Types

9. Conclusion

Chapter 2 Factors Contributing to Immunogenicity of Therapeutic Proteins and Clinical Consequences

Dr Steven Swanson, Department of Clinical Immunology, Amgen Inc, USA

1. Factors contributing to immunogenicity 1.1. The role of aggregates 1.2. The role of oxidation and deamidation 1.3. The role of contaminants and impurities

1.4. Role of sequences within the protein therapeutic 1.5. Ro
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