Associates of Cape Cod (ACC) and MDS Analytical Technologies Collaborate
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ACC and MDS Analytical Technologies collaborated on an FDA 21 CFR part 11 solution for ACC’s Chromogenic LAL Endotoxin assay kits. The partnership was based on ACC’s validation of MDS Analytical Technologies’ VersaMax™ monochromator-based absorbance microplate reader using the SoftMax® Pro GxP software compliant environment.
ACC offers several chromogenic assays: Pyrochrome® and Chromo-LAL for endotoxin detection and Glucatell® to detect (1,3)-ß-D-glucan in industrial applications. All methods are optimized for use in microplate detection systems such as the VersaMax™ reader.
SoftMax® Pro 5 GxP software from MDS Analytical Technologies is the industry standard microplate analysis software, offering extensive data capture and analysis capabilities in a FDA 21 CFR Part 11 compliant environment for MDS Analytical Technologies’ SpectraMax® line of microplate readers. It includes features that make it particularly well suited to endotoxin and glucan assays.
“We are proud to partner with one of the world’s largest manufacturers of assay kits to detect endotoxin in drugs and biological products”, said Andy Boorn, President of MDS Analytical Technologies. “Our pharmaceutical and biotechnology customers performing tests on the SpectraMax instrument platform can now increase their capital asset utilization by running LAL assays on SpectraMax readers. In addition, they can leverage the FDA 21 CFR Part 11 compliant system setup with SoftMax Pro GxP software reducing additional compliance costs required with third-party vendor solutions.”
ACC President & CEO A.J. Meuse, Ph.D. added, “Partnering with MDS Analytical Technologies, one of the premier bioanalytical instrument companies in the world, further strengthens our ability to meet the variety of instrument and software requirements our customers have for endotoxin and (1,3)-ß-D-glucan analysis. We are pleased to offer our customers the VersaMax™ plate reader which provides additional functionality for product release testing in an FDA 21 CFR Part 11 compliant environment.”
Customized assay methods for Chromo-LAL, Glucatell®, Glucatell®Diazo, Pyrochrome®, Pyrochrome® Diazo assay kits are available for SoftMax® Pro software version 5.2 GxP and greater.
