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How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations ☆

Paper ID Volume ID Publish Year Pages File Format Full-Text
33873 44995 2009 7 PDF Available
Title
How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations ☆
Abstract

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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How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations ☆
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Publisher
Database: Elsevier - ScienceDirect
Journal: New Biotechnology - Volume 25, Issue 5, June 2009, Pages 280–286
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us