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Outsourcing in bioanalysis: a CRO perspective.

Stephen Lowes1

  • 1Bioanalytical & ADME Laboratories, Q2 Solutions, 19 Brown Road, Ithaca, NY 14850, USA.

Bioanalysis
|August 23, 2017
PubMed
Summary

Steve Lowes discusses outsourcing strategy implementation in regulated bioanalysis, emphasizing liquid chromatography-mass spectrometry (LC-MS) applications. His expertise spans small and large molecules, including biomarker assays, for enhanced drug development.

Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry

Background:

  • Steve Lowes has extensive experience in regulated bioanalysis, focusing on liquid chromatography-mass spectrometry (LC-MS).
  • His career includes roles at VG Biotech, Waters Corporation, Advion, and currently Q2 Solutions.
  • He is a founding member of the Global Bioanalysis Consortium and a past-chair of the AAPS Bioanalytical Focus Group.

Purpose of the Study:

  • To discuss the implementation of outsourcing strategies in the context of regulated bioanalysis.
  • To highlight the role and expertise of Q2 Solutions in bioanalytical services.
  • To share insights on the application of LC-MS in small molecule and biomolecule analysis.

Main Methods:

  • Discussion of outsourcing strategy implementation.
  • Focus on liquid chromatography-mass spectrometry (LC-MS) techniques.

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  • Application in biomarker assay development.

    • Main Results:

    • Steve Lowes leads scientific disciplines in LC-MS bioanalysis at Q2 Solutions.
    • Expertise covers both small molecule and biomolecule applications.
    • Over 40 peer-reviewed publications and frequent conference presentations underscore his contributions.

    Conclusions:

    • Outsourcing strategies are crucial for efficient regulated bioanalysis.
    • Q2 Solutions offers specialized expertise in LC-MS bioanalysis for drug development.
    • Continued advancements in LC-MS are vital for biomarker and small/large molecule quantification.