IDBS Blog | 19th August 2013

Blog/Book of LC-MS Bioanalysis

The first ever comprehensive guide to experimental methodology for LC-MC bioanalysis (BA) is due to be published shortly. Edited by experts from Novartis Institutes for Biomedical Research, the Handbook of LC-MS Bioanalysis* is the result of an impressive collaboration from across a wide spectrum of the BA community spanning global pharma, regulators including the FDA and technology vendors. The Handbook looks likely to become the authoritative source on scientific, regulatory, quality and technology levers within the BA space.

All important aspects of LC-MS BA of both small molecules and macromolecules is provided and it includes perspectives on some advanced, and also emerging, technologies such as high resolution mass spectrometry, accelerator mass spectrometry and microsampling. The future state of BA and how technology can be leveraged to further drug discovery is also examined.

As a contributor to the Handbook, I feel very excited by its potential to offer valuable scientific leadership in pharmaceutical drug discovery and development. Finally, the BA industry will have a timely update to help guide its scientists in developing robust LC-MS BA assay methods according to current regulations by describing best practices and providing experimental protocols.

My fellow collaborators and I contributed a chapter exploring ‘state of the art’ as it relates to the data management landscape of regulated BA. We examined the many pressures facing the BA community and broadly focused on demands from:

  • The copious amounts of data being generated as part of daily laboratory work
  • Disparate and highly specialized hardware and software systems required to perform routine BA and how these must form an integrated ecosystem rather than exist in a vacuum – a de facto reality yet to be realized
  • Stringent compliance requirements across all aspects of the BA workflow
  • The lack of formal regulatory guidance from governing bodies such as the FDA and EMA relating to software and data management systems

With deep domain expertise in BA, IDBS has gone from simply supporting the BA community to helping drive its future state, namely a paperless lab via its electronic laboratory notebook (ELN) solutions: E-WorkBook Suite. As disparate and highly specialized hardware and software systems perform today’s routine BA, the importance of developing an integrated ecosystem is imperative. Our genuine belief is that E-WorkBook Suite is the foremost tool to deliver this utopian vision.

The Handbook of LC-MS Bioanalysis represents an important progression in global BA and, from a purely personal perspective, being a small part of this new industry standard represents a definite career highlight.

*Wenkui Li (Editor), Jie Zhang (Editor), Francis L. S. Tse (Editor), Handbook of LC-MS Bioanalysis: Best Practices, Experimental Protocols, and Regulations [October 2013, Wiley; 1 edition)

This material is reproduced with permission of John Wiley & Sons, Inc.

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