Stuart Needleman, Aptuit’s President and Chief Operating Officer said, “Our legacy and experience in overcoming the challenges associated with cardiovascular targets representing a potential liability includes the screening of novel compounds on the hERG channel. We have a substantial record of success and extensive experience in achieving high quality data, economically, efficiently and in record time, reducing attrition by the fast progress we can make in lead optimization projects. Pharma companies looking to outsource hERG channel screening services can have the utmost confidence in Aptuit's abilities in mastering electrophysiological technology, and specifically in hERG platforms.”
Dr. Caterina Virginio, Head of the Electrophysiology Laboratory at The Aptuit Center for Drug Discovery & Development in Verona, Italy, cited the distinction in the hERG channel screening that Aptuit provides as compared to similar CRO offerings. “To reduce the loss of compound that could lead to potency underestimation, we handle compound solutions in glass; then we can follow up the compound assessment with manual patch-clamp technology and apply different assay conditions at physiological and room temperature. Our clients stand to benefit from our scientific knowledge of the cardiovascular area and the fast results that we achieve from the testing process. Of course, our integrated and comprehensive services allow for follow up with further preclinical in vitro and in vivo studies as required.”
Dr. Virginio stated that typically, the hERG channel assay conditions include three concentrations for the test compound; at least three replicates and positive and negative controls – all in a one week turnaround time. She added that the testing of the compound’s liability on the hERG channel using the same electrophysiology platform can be extended to hNav1.5 and hCav1.2 channels, main cardiac ion targets. The liability panel that consists of hERG, hNav1.5 and hCav1.2 channels complements the integrated risk assessment for cardiac liability potential of compounds, as recommended by ICH Topic S 7 B, The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.
Mr. Needleman concluded, “We want to make sure that pharma companies know that they can turn to us for sophisticated studies based on a reliable and distinctive legacy of specific experience with key electrophysiological technology platforms and our vast knowledge in the cardiovascular therapeutic area.”
For more information, please contact Maria Garvey at Delfino Marketing either by phone at 914-747-1400 or by email: maria@delfino.com.
Aptuit LLC provides the most complete set of integrated early to mid-phase development services in the pharmaceutical industry. Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Sterile Fill Finish & Formulation Development, Oral Dosage Form Development & Manufacture, Clinical Sciences, Consulting and Aptuit INDiGOÒ (a program that accelerates drug development) are offered as stand alone or integrated services. Fully integrated drug discovery & development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains five global facilities with approximately 800 employees in Europe and the United States, and has a strategic relationship with Laurus Labs in India. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
For more information about Aptuit, visit www.aptuit.com
