How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations-Reference-Cited by-同舟云学术

How to systematically evaluate immunogenicity of therapeutic proteins – regulatory considerations

Published:2009-06 Issue:5 Volume:25 Page:280-286
ISSN:1871-6784
Container-title:New Biotechnology
language:en
Short-container-title:New Biotechnology

Author:

Jahn Eva-Maria,Schneider Christian K.

Publisher

Elsevier BV

Subject

Molecular Biology,General Medicine,Bioengineering,Biotechnology

Reference17 articles.

1. Immunogenicity of therapeutic proteins: clinical implications and future prospects;Schellekens;Clin. Ther.,2002

2. European Medicines Agency. (2007) European Public Assessment Report (EPAR) for Refacto® http://www.emea.europa.eu/humandocs/Humans/EPAR/refacto/refacto.htm

3. European Medicines Agency. (2007) Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins EMEA/CHMP/BMWP/14327/2006 http://www.emea.europa.eu/htms/human/humanguidelines/multidiscipline.htm

4. Bioequivalence and the immunogenicity of biopharmaceuticals;Schellekens;Nat. Rev. Drug Discov.,2002

5. Antibody humanization: a case of the ‘Emperor's new clothes’?;Clark;Immunol. Today,2000

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