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Enliven: Bio analytical Techniques

Analysis of Small Molecule Drugs and Biologics using LC-MS based Platforms
Author(s): Mu Chen

Deadline for Submission: 01stMay 2016

Special Issue Release Date: 10th August 2016

Handling Editor:

Mu Chen
Senior Scientist
Bioanalytical Services, Frontage Laboratories, Inc., Exton, PA

Special Issue Synopsis:

Bioanalytical methods based on liquid chromatography-mass spectrometry (LC-MS) techniques play indispensable roles in pharmaceutical research and development. For both small molecule drug substances and therapeutic biologics, LC-MS (including LC-MS/MS) methods were widely utilized to support various analytical goals especially for the pre-clinical and clinical studies. These LC-MS based bioanalytical methods have advantages of high sensitivity, selectivity, short analysis time, to name a few.

Although it takes less time to develop and validate a LC-MS method for bioanalysis (especially for biologics, when compared to immunogenicity assay), numerous factors need to be considered in order to develop a reliable and robust method. In addition, due to regulatory reasons, LC-MS methods for drug substances need to be strictly validated to fulfil their intended analytical purposes. The current special issue will feature development and validation of highlighted bioanalytical methods. Moreover, the issue is intended to showcase the wide scope of applications of such LC-MS methods and the various techniques (pretreatment of biological matrix, quantitation methods, new instrumentation) that can be incorporated for method optimization.

The special issue would be interesting to analytical scientists in both pharmaceutical industry and academics. The published articles will also provide practical information for scientists from other fields who would like to exploit the power of LC-MS.

About Handling Editor:

During his graduate research at Rutgers University in New Jersey, USA, Dr. Chen closely studied mass spectrometry, including instrumentation, method development, and applications in bioanalytical, physical organic, and biochemical research. Specifically, Dr. Chen has 6+ years of hands-on research experience in the characterization of novel organic compounds, damaged nucleobases, and RNA oligonucleotides. Both gas phase (fragmentation, structure elucidation) and aqueous phase (pKa, concentrations) properties of these species were studied by using analytical methods based on mass spectrometry and LC-MS/MS. In 2014, Dr. Chen joined Frontage Labs, a leading CRO company in bioanalysis(Exton, PA). He was intensively involved in many research projects in which bioanalytical methods have been developed and applied to support pharmaceutical R&D. Having developed 20+ LC-MS/MS methods per year, he is experienced with HPLC separation, mass spectrometry optimization and instrumentation, and pretreatment of biological samples in various matrices, from both theoretical and practical perspectives.

Dr. Chen’s research involves development of novel bioanalytical techniques to support pharmaceutical research, including measurement of red blood cell partitioning of drugs, protein binding, microsampling of blood specimen, analyte derivatization, as well as quantitation of endogenous analytes. His recent interest has also shifted to quantitation of large molecule drugs (oligonucleotides, antibody drugs, peptides) by using both immunogenicity and mass spectrometry platforms.

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