Avista Pharma Solutions, Inc. has announced that the expansion and upgrades to the Analytical Laboratories at its Durham, North Carolina facility are now complete. These enhancements will enable the company to significantly increase its capacity with a comprehensive range of capabilities for its pharmaceutical and medical device clients.
Comprised of two laboratories, the Analytical Research and Development (ARD) and Quality Control (QC) labs have now doubled in size and expanded the service offerings as the result of Avista’s capital investment. The completed Analytical Laboratories’ systems and equipment include a Thermo Scientific Orbitrap High-Resolution Mass Spectrometer, Mass-Directed Preparative Chromatography, Agilent UPLC-tandem Quad MS, Waters H-class UPLCs with six-column switching capabilities and PDA/ELSD/CAD/Single Quad MS detectors, along with upgraded Laboratory Information Management System (LIMS), Empower™ 3 Chromatography Data Software and Agilent MassHunter software with Enterprise Content Manager.
“Expanding our laboratory and adding new service offerings reinforces our commitment to providing our clients with a world-class center of excellence to assist in their product development efforts,” said Patrick Walsh, Chief Executive Officer at Avista. “Our clients choose to work with us because our skilled teams are relentless in support of their project needs.”
Using these state-of-the-art systems and equipment, Avista’s full-service offering includes:
- Chromatographic method development for assay and related substances, potential genotoxic impurities, organic volatile impurities and residual solvents
- Spectral identification using upgraded FTIR, NMR and UV-Vis instrumentation
- Structural chemistry and impurity identification through accurate mass LC-MS and generation fragmentation (MSn), 1D and 2D NMR and preparative chromatography isolation
- Fate and purge studies
- Extractable/leachable studies
- Release and stability testing
(Source: Avista Pharma Solutions)
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