DEPARTMENT OF CHEMISTRY AND ENVIRONMENTAL SCIENCE SEMINAR SERIES FALL 2018 DATE: THURSDAY, DECEMBER 6, 2018 LOCATION: TIERNAN HALL – 373 TIME: 2:00 PM – 3:30 PM GUEST SPEAKER Naijun Wu Analytical Development Celgene Corporation Summit, NJ TOPIC High Speed Chromatography to Expedite Pharmaceutical Development ABSTRACT Fast chromatography has played a critical role in expediting pharmaceutical development during the last decade. In this presentation, various approaches to fast separation are demonstrated, their mechanisms are discussed, and high throughput screen systems are described. In coupling with ultra-high-pressure liquid chromatography (UHPLC) instrumentation, short columns packed with small particles and superficially porous packings have been used for fast liquid chromatographic separations. These column packing materials provide much lower mass transfer resistance and thus high-speed separation. Small particle packed columns also provide advantages for high speed separation in supercritical fluid chromatography (SFC). Additionally, SFC provides better selectivity and thus faster separation for chiral compounds compared to capillary gas chromatography (GC). Small internal diameter columns and / or hydrogen carrier gas can be used to increase separation speed in GC. Separation times were reduced from 30 – 60 min to seconds. It was demonstrated that high throughput screen systems with DoE software could speed up method development and optimization. BIOGRAPHY Dr. Naijun Wu received his Ph.D. degree in Analytical Chemistry in 2000 from Brigham Young University, Provo, Utah, under the direction of Professor Milton Lee, where he conducted pioneering research on Ultra-High Pressure Liquid Chromatography (UHPLC) or Ultra-high Performance Liquid Chromatography (UPLC) as well as fast gas chromatography (GC) and fast Supercritical Fluid Chromatography (SFC). He also holds a BS degree and an MSc degree in Chemistry from Nanjing University of Technology. Dr. Wu has authored and co-authored more than 50 papers and given more than 40 presentations at National and International Scientific Conferences. He has also authored three book chapters and multiple invited reviews. He is current editorial board member of Journal of Liquid
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DEPARTMENT OF CHEMISTRY AND ENVIRONMENTAL SCIENCE
SEMINAR SERIES
FALL 2018
DATE: THURSDAY, DECEMBER 6, 2018
LOCATION: TIERNAN HALL – 373
TIME: 2:00 PM – 3:30 PM
GUEST SPEAKER Naijun Wu
Analytical Development
Celgene Corporation
Summit, NJ
TOPIC High Speed Chromatography to Expedite Pharmaceutical Development
ABSTRACT Fast chromatography has played a critical role in expediting pharmaceutical development during
the last decade. In this presentation, various approaches to fast separation are demonstrated, their
mechanisms are discussed, and high throughput screen systems are described.
In coupling with ultra-high-pressure liquid chromatography (UHPLC) instrumentation, short
columns packed with small particles and superficially porous packings have been used for fast
liquid chromatographic separations. These column packing materials provide much lower mass
transfer resistance and thus high-speed separation. Small particle packed columns also provide
advantages for high speed separation in supercritical fluid chromatography (SFC). Additionally,
SFC provides better selectivity and thus faster separation for chiral compounds compared to
capillary gas chromatography (GC). Small internal diameter columns and / or hydrogen carrier
gas can be used to increase separation speed in GC. Separation times were reduced from 30 – 60
min to seconds.
It was demonstrated that high throughput screen systems with DoE software could speed up
method development and optimization.
BIOGRAPHY Dr. Naijun Wu received his Ph.D. degree in Analytical Chemistry in 2000 from Brigham Young
University, Provo, Utah, under the direction of Professor Milton Lee, where he conducted
pioneering research on Ultra-High Pressure Liquid Chromatography (UHPLC) or Ultra-high
Performance Liquid Chromatography (UPLC) as well as fast gas chromatography (GC) and fast
Supercritical Fluid Chromatography (SFC). He also holds a BS degree and an MSc degree in
Chemistry from Nanjing University of Technology.
Dr. Wu has authored and co-authored more than 50 papers and given more than 40 presentations
at National and International Scientific Conferences. He has also authored three book chapters
and multiple invited reviews. He is current editorial board member of Journal of Liquid
Chromatography and Related Technologies. His research has focused on high-speed LC
separation using UHPLC /UPLC and novel column technologies for pharmaceuticals. His other
research interests include fast LC screening, fast GC, fast chiral SFC, and thermodynamics in
HPLC.
Dr. Wu is currently Director of Analytical Development, Celgene Corporation, directing 20+
Ph.D. and M.Sc. scientists on analytical research and development. He has more than eighteen
years of leadership and scientific experience in analytical R&D functions with increasing
responsibilities in supporting drug substance and formulation development, process scale-up,
technology transfer, regulatory registration and in-line supply of API and solid and parenteral
products from pre-clinical to registration phases. He is managing all the analytical aspects
including method development, validation release testing, stability, supporting API and
formulation development, and filings. Priorto Celgene, he worked with Merck for 12 years in
Analytical R&D Department. Between1990 and 1995, he worked as an assistant professor and
assistant chair at Applied Chemistry Department of Nanjing University of Technology.
Naijun Wu’s Publications Book Chapters
1. Naijun Wu, Christopher J. Welch, Theresa K. Natishan, Hong Gao, Tilak Chandrasekaran, and
Li Zhang, Chapter 3: “Practical Aspects of Ultrahigh Performance Liquid Chromatography,” in
Ultra-High Performance Liquid Chromatography and Its Applications, Ed. By Alan Xu, p.40-94,
2013, John Wiley & Sons, Inc., Hoboken, New Jersey.
2. Wu, N.; Li, Z. "Applications of Monolithic Chromatography in Support of Pharmaceutical
Development of Drug Substances and Formulations," in "Monolithic Chromatography and Its
Modern Applications", Ed. by Perry Wang, ILM Publications, Chapter 15, p.427-449, 2010.
3. Wu, N. “Increasing the Speed of Enantiomeric Separation Using Supercritical Fluid
Chromatography,” in Advances in Chromatography, Schmidt Periodicals GmbH, Germany,
2007, Vol. 46, Chapter 4.
Peer-reviewed Papers 1. T. Nowak, G. C. Graffius, Y. Liu, N. Wu, X. Bu, X. Gong, C. J. Welch, E. L. Regalado, “GC-
FID method for high-throughput analysis of residual solvents in pharmaceutical drugs and
intermediates.” Green Chem., 2016, 18, 3732-373
2. M Biba, EL Regalado, N Wu, CJ Welch, “Effect of particle size on the speed and resolution of
chiral separations using supercritical fluid chromatography,” J. Chromatogr. A, 2014, 1363, 250-
256.
3. Wu, N.*; Bradley, A. C. “Effect of column dimension on observed column efficiency in ultra-
high pressure liquid chromatography,” J. Chromatogr. A 2012, 1261:113-120.
4. Wu N, Bradley AC, Welch CJ, Zhang L., “Effect of extra-column volume on practical
chromatographic parameters of sub-2-µm particle-packed columns in ultra-high pressure liquid
chromatography,” J. Separation Science. 2012, 35, 2018-2015.