A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
| Autor: | Gopi Shankar, Charles Pendley, Kathryn E Stein |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Bioanalysis
Drug-Related Side Effects and Adverse Reactions animal diseases Innate immunology Biomedical Engineering chemical and pharmacologic phenomena Bioengineering Pharmacology Risk Assessment Applied Microbiology and Biotechnology Autoimmune Diseases Biological drugs Immune system Risk Factors Immunity Drug approval Humans Medicine Drug Approval biology business.industry Models Immunological biochemical phenomena metabolism and nutrition Immunity Innate Immunology biology.protein bacteria Molecular Medicine Antibody business Biotechnology |
| Zdroj: | Nature Biotechnology. 25:555-561 |
| ISSN: | 1546-1696 1087-0156 |
| DOI: | 10.1038/nbt1303 |
| Popis: | Bioanalytical assessments of anti-drug antibodies (ADAs) provide an understanding of the immunogenicity of biological drug molecules. The potential to induce ADAs after treatment with biologics is a safety issue that has become an important consideration in the development of biologics and a critical aspect of regulatory filings. US and European regulatory agencies are recommending that sponsors study immunogenicity using a risk-based approach, encouraging sponsors to formulate and implement their own risk management plans and to conduct discussions with the agencies when necessary. It follows from this that the greater the safety risks of ADAs, the more diligently one should clarify the immunogenicity of the product. Here we propose a general strategy to broadly assign immunogenicity risk levels to biological drug products, and present risk level-based 'fit-for-purpose' bioanalytical schemes for the investigations of treatment-related ADAs in clinical and nonclinical studies. |
| Databáze: | OpenAIRE |
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