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Immunogenicity to Biologics
Biopharm Knowledge Publishing, Nov 2007, Pages: 170
Implications of reactions against biotech drugs
Understanding immunogenicity, a detrimental and potentially dangerous response to therapeutic proteins, is vitally important for the successful development and marketing of biotech drugs. Failure to predict and minimise levels of immunogenicity may have harmful and sometimes disastrous results for both patients and the industry.
This comprehensive new report written by leaders in the field, gives you the information you need to understand immunogenicity and to implement relevant safety strategies. The commercial implications are covered in a section written by experts at PricewaterhouseCoopers (PwC).
This unique 170-page report includes chapters by the following industry experts:
- Dr Stephen Swanson, Director, Clinical Immunology, Amgen
- Meenu Wadhwa, Head, Cytokines and Growth Factors, Biotherapeutics, NIBSC
- Robin Thorpe, Head, Biotherapeutics, NIBSC
- Dr Deborah Finco-Kent, Immunogenicity Lead, Drug Safety R&D, Pfizer
- Dr Ingrid Caras, Senior Director, Bioanalytical & Development Sciences, PDL Biopharma,
- Dr Bonita Rup, Senior Director, Bioanalytical R&D, Drug Safety and Metabolism, Wyeth Research
- Dr Christian Schneider, Acting Head, EU Cooperation/Microbiology, Paul-Ehrlich-Institute
- Dr Harald Kropshofer, Global Coordinator & Head, Immunosafety of Biologics, F. Hoffman La Roche
Plus an additional chapter on the commercial implications by PwC experts Jo Pisani and Yann Bonduelle.
This report will enable you to:
- Understand the processes involved in immunogenicity
- Find out how immunogenicity impacts on safety and efficacy
- Grasp the commercial implications
- Work out an immunogenicity assessment strategy
- Manage your cooperation with the FDA and EMEA
- Prepare for new launches
Contents include:
- Factors contributing to immunogenicity
- Impact on safety and efficacy
- 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 biotech, biosimilars and pharmaceuticals, and for contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an authoritative, detailed and clear explanation of the issues surrounding immunogenicity and its implications for the market and the biotech, biosimilar and pharmaceutical industries.
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