AB Sciex LLC this week launched new software and service offerings to simplify and accelerate the integration of micro LC technology into regulated bioanalytical laboratories. The addition of a new software module supporting 21CFR Part 11 and a new IQ/OQ/PQ service to the Eksigent line of liquid chromatography solutions gives pharmaceutical companies, contract research organizations and other high-throughput laboratories the opportunity to use a validated approach to micro LC for increasing sensitivity and speed while reducing the cost of running a laboratory.
Regulated bioanalytical labs have been looking for ways to improve productivity and efficiency for their ADME and bioanalysis assays but haven’t been able to take advantage of micro LC because of the lack of tools and precedence to integrate it into an existing lab that follows GLP regulations. The new 21CFR Part 11 module and the new service to qualify the LC system for GLP solve this dilemma for regulated labs by eliminating any doubt that a micro LC solution can be configured to meet required rules and regulations.
For researchers looking for improved sensitivity, efficiency and cost savings, micro LC technology, such as the Eksigent ekspert microLC 200 UHPLC system, delivers up to a 4x increase in sensitivity and as much as a 3x increase in throughput while minimizing sample injection volumes. It also can reduce solvent consumption and costs by up to 95%.
Among the regulated labs that are using micro LC is Alturas Analytics Inc., a contract research organization that provides LC/MS-based services to the pharmaceutical and biotech industries. Scientists at Alturas are using an Eksigent micro LC solution along with AB SCIEX QTRAP technology for an integrated quantitative/qualitative approach.
“By improving the limits of detection with micro LC technology, regulated labs can improve results in bioanalysis,” said Shane Needham, Ph.D., Lab Director, Alturas Analytics, Inc. “The availability of the 21CFR Part 11 software module is significant because now we can use micro LC for assays that require regulatory compliance, which gives CROs like us a competitive advantage.”
AB SCIEX’s industry-leading, Ekisgent-branded micro LC solutions complement its line of analytical flow LC and nano LC solutions. The company expanded its chromatography product portfolio in 2012, delivering simplified UHPLC-MS solutions that are tailor-made for a variety of applications.
“AB SCIEX is driving a ‘micro LC for the masses’ philosophy, simplifying the integration of micro LC technology into an existing high-throughput laboratory,” said Ben Moshiri, Ph.D, Director of the Separations Business, AB SCIEX. “End-users can improve productivity, get faster inject-to-inject times, higher sensitivity and reduced costs with the microLC 200 system. We are now enabling the regulated market to take advantage of the power of micro LC in ways that non-regulated markets have known for years.”
The new qualification services for the micro LC and mass spectrometers will provide testing and documentation to verify the proper installation and operation of the system hardware. Additionally, the LCMS PQ will test and document the overall performance of the micro LC and mass spectrometry instrumentation as a complete system. The new software module supporting 21CFR Part 11, in conjunction with these qualification services, provides a comprehensive solution that supports customers in achieving a compliant use of these systems for regulated labs.
Source: AB SCIEX