| How to systematically evaluate immunogenicity of therapeutic proteins - regulatory considerations. | |
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MedLine Citation:
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PMID: 19491045 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Antibody formation as an immune reaction to a 'foreign' protein antigen is an expected physiological reaction that is in many cases intentionally triggered, for example in the case of vaccinations. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) issued a multidisciplinary guideline providing general recommendations from a marketing authorisation perspective on how to assess an unwanted immune response following the administration of a biological drug. In this article, we provide an in-depth regulatory discussion on key principles of systematic evaluation of immunogenicity during development of biotechnological medicinal products, including examples. |
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Authors:
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Eva-Maria Jahn; Christian K Schneider |
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Publication Detail:
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Type: Journal Article; Review Date: 2009-04-05 |
Journal Detail:
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Title: New biotechnology Volume: 25 ISSN: 1871-6784 ISO Abbreviation: N Biotechnol Publication Date: 2009 Jun |
Date Detail:
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Created Date: 2009-06-03 Completed Date: 2009-08-12 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101465345 Medline TA: N Biotechnol Country: Netherlands |
Other Details:
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Languages: eng Pagination: 280-6 Citation Subset: IM |
Affiliation:
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Paul-Ehrlich-Institut, Division EU Cooperation/Microbiology, Langen, Germany. schci@pei.de <schci@pei.de> |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biological Products
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administration & dosage*,
analysis,
immunology Biotechnology Drug Approval / organization & administration* Drug Industry Guidelines as Topic Humans Immunity* Legislation, Drug Marketing Pharmaceutical Preparations / adverse effects Proteins / immunology*, therapeutic use* Risk Factors |
| Chemical | |
Reg. No./Substance:
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0/Biological Products; 0/Pharmaceutical Preparations; 0/Proteins |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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