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

Journal of Immunological Methods
Christina HermanrudABIRISK Consortium

Abstract

Neutralizing anti-drug antibodies (NAbs) against therapeutic interferon beta (IFNβ) in people with multiple sclerosis (MS) are measured with cell-based bioassays. The aim of this study was to redevelop and validate two luciferase reporter-gene bioassays, LUC and iLite, using a cut-point approach to identify NAb positive samples. Such an approach is favored by the pharmaceutical industry and governmental regulatory agencies as it has a clear statistical basis and overcomes the limitations of the current assays based on the Kawade principle. The work was conducted following the latest assay guidelines. The assays were re-developed and validated as part of the "Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk" (ABIRISK) consortium and involved a joint collaboration between four academic laboratories and two pharmaceutical companies. The LUC assay was validated at Innsbruck Medical University (LUCIMU) and at Rigshospitalet (LUCRH) Copenhagen, and the iLite assay at Karolinska Institutet, Stockholm. For both assays, the optimal serum sample concentration in relation to sensitivity and recovery was 2.5% (v/v) in assay media. A Shapiro-Wilk test indicated a normal distribution for...Continue Reading

References

Jan 7, 1999·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·E PungorS E Grossberg
Jun 6, 2000·Journal of Biomolecular Screening·J H ZhangK R Oldenburg
Sep 29, 2001·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·S E GrossbergJ P Klein
Oct 4, 2007·Journal of Neurology, Neurosurgery, and Psychiatry·A SominandaA Fogdell-Hahn
Jul 3, 2008·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·C LallemandM G Tovey
Nov 11, 2008·Journal of Pharmaceutical and Biomedical Analysis·Gopi ShankarEugen Koren
Nov 4, 2009·Neurology·Andrew R PachnerUNKNOWN INSIGHT investigators
Feb 14, 2012·Pharmaceutical Statistics·J L Sebaugh
Jan 22, 2014·Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research·Christina HermanrudAnna Fogdell-Hahn

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Citations

Apr 27, 2012·PloS One·Yaoqing ChenHuimin Yan
Oct 21, 2017·Multiple Sclerosis Journal - Experimental, Translational and Clinical·Alexander Y LauEric Chan
Jun 8, 2018·JCI Insight·Marsilio AdrianiUNKNOWN ABIRISK Consortium

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