Taking immunogenicity assessment of therapeutic proteins to the next level

Author:

Büttel I.C.,Chamberlain P.,Chowers Y.,Ehmann F.,Greinacher A.,Jefferis R.,Kramer D.,Kropshofer H.,Lloyd P.,Lubiniecki A.,Krause R.,Mire-Sluis A.,Platts-Mills T.,Ragheb J.A.,Reipert B.M.,Schellekens H.,Seitz R.,Stas P.,Subramanyam M.,Thorpe R.,Trouvin J.-H.,Weise M.,Windisch J.,Schneider C.K.

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference49 articles.

1. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins;European Medicines Agency – Committee for Medicinal Products for Human Use (CHMP),2007

2. A European perspective on immunogenicity evaluation;Schneider;Nat Biotechnol,2009

3. Concept paper on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use;European Medicines Agency – Committee for Medicinal Products for Human Use (CHMP),2009

4. Comparability of biotechnological/biological products. Note for guidance on biotechnological/biological products subject to changes in their manufacturing process (CPMP/ICH/5721/03);European Medicines Agency – ICH Topic Q 5 E,2005

5. Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues;European Medicines Agency – Committee for Proprietary Medicinal Products (CPMP),2003

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