Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development

Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development provides a valuable “go-to” reference for many difficult-to-solve challenges using pertinent chromatographic theory, first-hand case studies, and examples provided from academic and industry experts. This text also enables professors teaching an analytical instrumental course to introduce and instruct students about one of the most sustainable and powerful separation methods currently available. While the text has broad applicability across industrial sectors, it focuses primarily on application in the pharmaceutical industry. The book is designed to allow readers to align current HPLC/UHPLC capabilities with SFC as an orthogonal tool for project specific methods in the pharmaceutical industry. It highlights where SFC falls on the spectrum of useful chromatographic tools for routine and challenging separative methods.

Experienced HPLC users who are interested in developing knowledge in orthogonal separation techniques, as well as newcomers to the field of separation science, will find this text particularly useful. Chapters address where SFC may fit the analytical needs of the pharmaceutical industry and alert the readers as to where the technique will not fit. Readers will gain an understanding of how and where SFC may be applied and adapted more routinely across the pharmaceutical industry as a ‘green’ way of undertaking separation opportunities and challenges. Areas within the pharmaceutical industry include early drug discovery, process chemistry, and late stage development and manufacturing.

• Describes approaches to SFC column and mobile phase selection for method development for both analytical and preparative tasks
• Gives practical examples of how analytical SFC enables the monitoring of synthetic reactions including unstable intermediates, chiral and achiral polar reactants and products across small and large modalities
• Provides need-focused case studies for pharmaceutical analysts, process chemists, and contract chemistry facilities that can benefit from monitoring or purifying polar intermediates, mutagenic impurities, nitrosamines and other reaction by-products including excipients and metabolites

Dr. Michael Hicks has over 20 years of pharmaceutical research experience. Dr. Hicks started in Analytical Research and Development in 1989 at Merck, received his PhD from Seton Hall University in 1997. He taught an Advanced Biomedical Engineering Graduate Laboratory at the Stevens Institute of Technology as adjunct faculty for ten years. He served as the 2017 Program Director for the Eastern Analytical Symposium and is an affiliate member of the EAS Board of Directors. He leads the Analytical Chemistry sub team of the Pharmaceutical Chemistry Roundtable for the ACS Green Chemistry Initiative Global Consortium. He is currently in the Analytical Chemistry and Enabling Technologies group in the Analytical R & D Department at Merck Research Labs in Rahway NJ specializing in separations, particularly in supercritical fluid chromatography as well as other large molecule method like size exclusion with multi-angle light scattering.

Dr. Paul Ferguson is a separation science specialist at AstraZeneca in the UK. He has worked in the pharmaceutical industry since 1999. Paul has interests in (U)HPLC, SFC, CE, chiral separations, formulated drug sample preparation, green analytical chemistry and chromatographic method development. He is a past winner of the Desty Memorial lecture prize (2002), a Fellow and Chartered Chemist in the Royal Society of Chemistry and lectures on his research interests at various UK universities. He has published over 20 peer-reviewed papers, 3 book chapters on aspects of green analytical chemistry and sits on the editorial advisory board for LCGC magazine. Paul is also Honorary Secretary of The Chromatographic Society in the UK. He has previously served as Vice-President for the Society from 2009 to 2014 and President from 2014 to 2017.