AB SCIEX Drives Expanded Use of Micro LC for Regulated Bioanalysis With
Enhanced Eksigent Software and Services
Introduction of 21CFR Part 11 module for software control of Eksigent systems
to accelerate adoption of micro LC technology
FRAMINGHAM, Mass. -- March 18, 2013
AB Sciex LLC, a global leader in analytical technology, today announced the
availability of 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.
About AB SCIEX
AB SCIEX helps to improve the world we live in by enabling scientists and
laboratory analysts to push the limits in their field and address the complex
analytical challenges they face. The company’s global leadership and
world-class service and support in the mass spectrometry industry have made it
a trusted partner to thousands of the scientists and lab analysts worldwide
who are focused on basic research, drug discovery and development, food and
environmental testing, forensics and clinical research. With 30 years of
proven innovation, AB SCIEX excels by listening to and understanding the
ever-evolving needs of its customers to develop reliable, sensitive and
intuitive solutions that continue to redefine what is achievable in routine
and complex analysis. For more information about the company, go to
www.absciex.com. Follow AB SCIEX on Twitter @ABSCIEX, Facebook and LinkedIn.
© 2013. AB SCIEX. AB Sciex Instruments Are For Research Use Only. Not for use
in diagnostic procedures. The trademarks mentioned herein are the property of
AB SciexPte. Ltd. or their respective owners. Eksigent is a part of AB Sciex,
LLC. AB SCIEX^TM is being used under license.
Anthony Petrucci, 1-508-383-7961
Director of Public Relations
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