The method history report: an adaptable tool for communicating immunogenicity assay development and validation
| Autor: | Robert J. Konrad, Jessie L. Bishop, Kristin Hollister, Nicoletta Bivi, Margaret A Gardner, Jeff W. Cramer, Michael E Hodsdon, Huy T Nguyen |
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| Rok vydání: | 2020 |
| Předmět: |
0303 health sciences
business.industry Immunogenicity 010401 analytical chemistry Clinical Biochemistry Therapeutic protein General Medicine Computational biology Validation Studies as Topic 01 natural sciences 0104 chemical sciences Analytical Chemistry 03 medical and health sciences Medical Laboratory Technology Humans Biologics License Application Medicine Biological Assay General Pharmacology Toxicology and Pharmaceutics business 030304 developmental biology |
| Zdroj: | Bioanalysis. 12:1597-1605 |
| ISSN: | 1757-6199 1757-6180 |
| Popis: | Over the developmental lifetime of a therapeutic protein, the immunogenicity assay validation history can become substantial, frustrating review of clinical immunogenicity within the biologics license application. In our experience, this can lead to questions by regulators, resulting in numerous information requests during the review process. To address this, we propose a new document, the method history report (MHR), which can comprehensively present the history of the immunogenicity assay for regulators, including assay development and validation. The flexibility of the MHR allows for adaptation to the specific needs of each therapeutic program, while maintaining a consistent template. Here, we detail the rationale, general outline and template for the MHR and recommend others consider adopting it for their biologics license application-related activities. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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