Gyrolab Spin Blog: clinical-trial

Apr 6, 2020 8:18:21 PM

Enhancing the productivity of immunoassays: a 2-plex Gyrolab® assay for both preclinical and clinical studies

Target-specific reagents and immunoassay formats smoothen validation and transfer between CMC, preclinical, and clinical applications, and also to a CRO

Enhancing the productivity of immunoassays: a 2-plex Gyrolab assay for both preclinical and clinical studieRobust, accurate, precise, and time effective ligand binding assay platforms are crucial for the development of advanced bioassays for analyzing therapeutic antibody mixtures due to the inherent complexity of these drugs. This is why Symphogen A/S, Denmark chose Gyrolab system to develop assays to support chemistry, manufacturing, and controls (CMC) release and stability programs, and pharmacokinetics preclinical and clinical studies on Sym015, a novel anti-cancer biotherapeutic comprising two humanized monoclonal antibodies (mAbs).

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Topics: Pharmacokinetics, Clinical trial, Preclinical studies, CRO transfer

Apr 25, 2018 2:22:39 PM

How to overcome disease-specific matrix interference

Minimize incubation times with flow-through immunoassays

dropMatrix interference can be a major challenge in the development of immunoassays to study a number of disease states. Kathi Williams and her colleagues at Genentech Inc., USA, experienced considerable problems with matrix interference when developing an ELISA for Phase III studies of a humanized monoclonal antibody when a new patient group was introduced. The solution was to transfer the assay to the Gyrolab platform that, thanks to its flow-through technology helped minimizing matrix effects by reducing the incubation times with the capture reagent antibody.

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Topics: Matrix, Pharmacokinetics, Immunoassay, Clinical trial, Phase III studies, Ulcerative colitis, Crohn's disease