AstraZeneca purchases In vitro technology application, Galileo(TM) LIMS, from InnaPhase Corporation
The Galileo(TM) LIMS solution is a comprehensive, GLP and 21 CFR Part 11 compliant, procedure-based LIMS for the design of in vitro studies, sample bioanalysis, and data calculation for permeability, metabolic stability, enzyme inhibition (IC(50) and K(i)), mechanism-based inactivation, and protein binding experiments. In vitro experiments in Galileo are defined using an integrated task manager, with built-in analytical instrument interfacing, calibration curve regression, a graphics gallery for data review and reporting, and includes an integrated document management system. Galileo is a security-controlled, audit-trailed environment using an Oracle 9i database.
"One of AstraZeneca's key priorities is continuous improvement in our overall productivity and efficiency to enable us to meet our target of delivering new, medically important and commercially successful medicines to market every year," said Dave Sweetmore, Business Project Manager. "We have been impressed with the use of InnaPhase's Watson LIMS solution in our bioanalytical laboratory and we are certain that Galileo will produce the same outstanding results for our in vitro studies."
"In vitro data is increasingly being scrutinized because of its importance in obtaining BCS biowaivers as justification for not conducting clinical bioequivalence studies," said Dr. Jo Webber, CEO and President of InnaPhase Corporation. "Since the in vitro data is being submitted to the FDA, the ability to conduct in vitro experiments in a GLP compliant manner is critical and we are pleased that AstraZeneca has chosen Galileo, a `must have' solution for in vitro studies."
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