Validated CiPA Cardiac Safety Services

Trust Us With Your Cardiac Safety Program!

As an industry leader in safety pharmacology, Eurofins Discovery was the first CRO to provide testing by automated patch clamp electrophysiology. Let us bring our expertise to your cardiac safety screening needs!
 
Many drugs withdrawn from the market due to cardiac-related adverse effects block the human ether-a-go-go (hERG) ion channel. However, well-known marketed drugs that inhibit hERG, prolong action potentials and extend QT interval duration are routinely used in clinical medicine because they carry extremely low risk of Torsades de Pointes (TdP).To identify drugs with a low risk of pro-arrhythmic events like TdP, even in the presence of hERG inhibition or QT prolongation, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative was established.
 
The core components of a CiPA harmonized assessment address the effects of candidate drugs on the sodium (Na+), calcium (Ca2+), and potassium (hERG-K+) cardiac ion channels, as they play key roles in governance of the cardiac action potential. These channels are responsible for ventricular depolarization, plateau phase, and repolarization, respectively.
 
Eurofins recommends the following services to address the complex demands of cardiac safety liability testing:

Stable and Robust CiPA hERG Assay at Physiologic Temperature

CiPA hERG Assay at 37ºC
Stable and robust CiPA hERG Assay at 37ºC

Figure 1. Peak human CiPA hERG recommended voltage protocol at 37°C shows the pattern typical of cardiac repolarization. CiPA voltage protocols (red line, left hand plot) used to measure peak current is plotted with the measurement region of leak and peak currents indicated (green bars). Recording stability (right plot) is indicated by traces for peak and leak current (filled circle and square, left y-axis) and assay temperature (filled triangle, right y-axis). Current and temperature are plotted against time (x axis) and were taken over a 15 min time period.

Key Areas

Eurofins Discovery’s scientists have successfully developed and validated assays for assessing safety risk potential for patients with cardiac liability, with human induced pluripotent stem-cell cardiomyocyte assays.

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