Mass spectrometry systems enable sensitivity in drug trials

The International Pharmaceutical Research Center (IPRC) in Jordan is investing in two AB SCIEX Triple Quad 6500 LC/MS/MS systems in order to offer new capabilities for bioanalysis studies of Phase I clinical trial compounds. The sensitivity of the systems will enable the IPRC to detect drug compounds or metabolites in human samples down to femtogram levels for the first time, as well as increasing significantly the IPRC’s daily sample throughput.

IPRC is a privately owned CRO that has been providing clinical services, including Phase I bioanalysis studies, for pharmaceutical companies worldwide since 1997. The CRO conducted over 1000 bioavailability and bioequivalence studies to date and has been relying on AB SCIEX mass spectrometry hardware and software for 17 years. Its five teams of chemists run eight mass spectrometry systems for 24 hours per day, in order to process hundreds of thousands of samples per year.

The 6500 system with Ion Drive Technology increases the quantity of ions produced while enhancing the way ions are transmitted and detected, increasing the limits of quantitation. According to Dr Isam Salem, vice president, operations, IPRC, the systems will “make a significant different to our capabilities as well as to our productivity”.

“We will be able to provide Phase I clinical trials for inhaled drugs and hormones for the first time, thanks to the extreme sensitivity of the 6500 Triple Quads,” Dr Salem said. “They will enable us to determine with confidence whether or not inhaled drugs are absorbed into the general circulation, even at the femtogram level.

“It’s critical that we have absolute confidence in the quality and robustness of our data when submitting clinical trials results to the regulatory bodies,” added Dr Salem. “We have always depended on AB SCIEX hardware and software systems. We have a long and collaborative relationship with the company, based on its excellent support and high-quality instruments, which have never once let us down.”