Development and validation of cell-based luciferase reporter gene assays for measuring neutralizing anti-drug antibodies against interferon beta

Author:

Hermanrud Christina,Ryner Malin,Luft ThomasORCID,Jensen Poul Erik,Ingenhoven Kathleen,Rat Dorothea,Deisenhammer Florian,Sørensen Per Soelberg,Pallardy Marc,Sikkema Dan,Bertotti Elisa,Kramer Daniel,Creeke Paul,Fogdell-Hahn Anna

Publisher

Elsevier BV

Subject

Immunology,Immunology and Allergy

Reference22 articles.

1. Development and validation of a real time PCR-based bioassay for quantification of neutralizing antibodies against human interferon-beta;Bertolotto;J. Immunol. Methods,2007

2. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins;EMA;European Medicines Agency,2008

3. Neutralizing anti-interferon beta antibodies are associated with reduced side effects and delayed impact on efficacy of interferon-beta;Farrell;Mult. Scler.,2008

4. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins;FDA;USA Food and Drug Administration,2009

5. The neutralization of interferons by antibody. II. Neutralizing antibody unitage and its relationship to bioassay sensitivity: the tenfold reduction unit;Grossberg;J. Interf. Cytokine Res.,2001

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