Drug Discovery 2022: driving the next life science revolution

Cardiosafety Testing Based on CiPA - at Scale with SyncroPatch 384 and Genedata Screener


S Stoelzle-Feix1; A Yee2; MG Rotordam3; M Ginkel2; N Brinkwirth3; G Nass Kovacs2; N Becker3; G Lemercier2; M Newman2; S Heyse2; S Steigele2
1 Nanion Technologies, Germany;  2 Genedata AG, Switzerland;  3 Nanion Technologies GmbH, Germany


As part of the Comprehensive In Vitro Proarrhythmia Assay (CiPA) initiative, the FDA and other medical agencies have collaborated with pharma companies, academics, CROs, and device companies to develop a more comprehensive, robust, mechanism-based in vitro assessment of arrhythmia risk for new drugs. The CiPA protocols consist of panels of standardized in-vitro assays, incorporating defined tests against major cardiac ion channels, and thus enable large-scale, early discovery screens for liability prediction. Here we present a tailored solution for upscaled and traceable cardiac safety studies performed according to the CiPA guidelines. A combination of automated patch clamp assays run on Nanion SyncroPatch 384 instruments with automatic processing of the resulting data in the Genedata Screener software enables comprehensive cardiac risk assessment on potentially thousands of compounds per week, following CiPA experimental and analysis guidelines. This integrated, efficient workflow enables collection of high-quality electrophysiological data, their rigorous analysis, and their collation with non-APC assays (e.g. impedance data) for final panel assessment. We demonstrate this using hERG and Nav1.5 assays conducted in compliance with CiPA recommendations on experimental procedures. Data processing, use of control data, data normalization,
visualization of recording quality over time and other quality control metrics, assay end results and cross-assay safety scores are all combined in a result package that provides a clear path for putative submission to regulatory authorities. The automation technology presented enables large-scale cardiac safety assessment of candidate molecules, comprehensive in quality and dimensionality and authoritative by virtue of data integrity and accessibility, to eliminate risks earlier in the process of therapeutic development.

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