Gyrolab Spin Blog: immunogenicity

Apr 6, 2020 8:18:44 PM

How to think about HCP impurity testing

Getting a meaningful result

How to think about HCP impurity testing

Many good points were raised when it comes to impurity testing at the latest Gyrolab User Seminar, held in Milan in June. This included a roundtable discussion on a subject that has been a stumbling block for many – how to measure Host Cell Protein (HCP) levels in a meaningful way.

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Topics: HCP, Immunogenicity, Impurity testing

Apr 25, 2016 3:09:07 PM

Finding the best platform for fit-for-purpose ADA assays

Gyrolab system delivers

ADA.pngDetermining the immunogenic potential of a therapeutic antibody is a regulatory requirement during clinical development since anti-drug antibodies (ADA) can cause undesirable effects, ranging from loss of drug exposure and efficacy to serious adverse events. Justine Brose and her colleagues at Novimmune SA, Geneva, Switzerland evaluated four platforms to determine which platform and sample pre-treatment procedures could deliver a fit-for-purpose assay for ADA analysis to determine the immunogenicity of the therapeutic antibody Novimab. Of the platforms tested (ELISA and Gyrolab, Meso Scale Discovery, and AlphaLISA platforms) only Gyrolab and MSD platforms met all of their pre-specified assay requirements.


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Topics: ADA, Immunogenicity