New ‘chiral center’ in Belgium promises to help drug firms comply with regulatory demands for quality and accelerate registration of new compounds.
The European Centre for Chirality (EC2), set up by the Universities of Ghent and Antwerp in Belgium and UK-based discovery firm BioTools Europe, will provide chiral analysis services to pharma firms when operational early in December.
EC2 COO Sergey Sergeyev predicted strong demand, suggesting that “[while] many pharmaceutical companies have a wide range of skills and equipment it is not always readily available and often it’s a preferred route to outsource the analysis on both efficiency and cost grounds.”
“In a sector where first to market is of extreme importance fast accurate registration or structural information leading to advancing the development or even early attrition can result in significant financial gains.”
Sergeyev also told in-PharmaTechnologist that industry regulators “strongly encourage the development of chiral drugs in the enantiomerically pure form and at the same time requires the study of all properties of the single enantiomers.”
This pressure, he continued, is reflected by the market, citing the fact that that 73 per cent of the small molecule drugs approved by the FDA between January 2004 and June 2006 were chiral and 65 per cent were single enantiomers.
Key techniques on offer at EC2 will include vibrational circular dichromism (VCD) analysis, which detects differences in circularly polarized light when passed through a sample providing information on its chiral form and Raman Optical Activity (ROA) spectroscopy.
The main advantage of these techniques, according to Frank Trundle, Managing Director, Biotools Europe, is that they allow the “absolute configuration of new molecular entities to be determined without the need for crystallization.”
He told in-PharmaTechnologist that: “EC2 will provide a support function for organizations that currently use VCD and ROA or wish to explore the value these techniques can bring to their research,” including capacity for feasibility studies, training and quantum chemical computational support.