Immunogenicity assessment of monoclonal antibody products: A simulated case study correlating antibody induction with clinical outcomes

Author:

Knezevic Ivana,Kang Hye-Na,Thorpe Robin

Publisher

Elsevier BV

Subject

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

Reference16 articles.

1. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins;Committee for Medicinal Products for Human Use,2007

2. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use;Committee for Medicinal Products for Human Use,2012

3. Taking immunogenicity assessment of therapeutic proteins to the next level;Büttel;Biologicals,2011

4. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products;Koren;J Immunol Methods,2008

5. Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology. Annex 4,2014

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