North Jersey Chromatography Group 

Registration:

Professionals: $ 10

Full-Time Students/Retired/Unemployed: Free

 

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Triumph Brewing Company

138 Nassau Street  

Princeton, NJ 08542

Presentation 1: Increasing Method Throughput with Ultra-High Pressure Liquid Chromatography

James Grinias, PhD, Assistant Professor

Department of Chemistry and Biochemistry, Rowan University

Presentation 2: Unique Separation Needs of Biologicals: An Examination of Superficially Porous Columns

Joseph Glajch, PhD, President

JLG AP Consulting LLC

Presentation 1: Increasing Method Throughput with Ultra-High Pressure Liquid Chromatography

Abstract:  One of today’s most widely used analytical tools is ultra-high pressure liquid chromatography (UHPLC). Compared to traditional HPLC techniques, UHPLC enables higher chromatographic efficiency and reduced method times, but requires two- to four-fold increases in system pressure. The use of superficially porous particles (SPPs) and quasi-adiabatic thermal environments can help maintain high efficiency as mobile phase velocity is increased, although broadening due to extra-column effects and viscous friction can still impact separation performance. The impact of these effects in various application areas will be explored in this presentation. A comparison of SPP columns of varying dimensions containing different particle sizes that was made to determine the best approach for reducing the analysis time of pharmacopeial monograph methods for over-the-counter analgesic drugs will also be discussed. System suitability parameters (resolution and peak asymmetry) and temperature changes across the axial length of the column were monitored at conditions near column or system pressure limits. Multiple methods were found to see a 10-to-20-fold improvement in throughput utilizing UHPLC, including a 20 second cycle time method for the separation of four compounds (two active pharmaceutical ingredients, one impurity, and one internal standard) maintaining a baseline resolution of 1.5 between all peaks. Considerations for the validation of these high-throughput methods will also be discussed.

About the Speaker:

Dr. James P. Grinias is an Assistant Professor in the Department of Chemistry and Biochemistry at Rowan University.  He received in B.S. in Chemistry from Eastern Michigan University, his Ph.D. in Analytical Chemistry from the University of North Carolina at Chapel Hill under the direction of Jim Jorgenson, and was an NIH NRSA Postdoctoral Research Fellow at the University of Michigan under the direction of Bob Kennedy.  He is the recipient of the HPLC 2013 Csaba Horváth Young Scientist Award, and was the 2017 Young Alumnus of the Year at Eastern Michigan University.

James’ research focuses on the fundamentals of separations in capillary and microfluidic columns. These techniques are also applied to help enhance analytical methods in the neuroscience, molecular physiology, and pharmaceutical fields. His work has led to nearly 20 peer-reviewed publications and dozens of presentations at national and international conferences.

In addition to his research interests, James is also interested in improving the educational experience of students in undergraduate analytical chemistry coursework. Specifically, he focuses on finding new ways of implementing new educational technologies to help enhance the instruction of chemical instrumentation and analytical techniques.

He has previously served the professional community as the Assistant Program Chair for the 2012 Southeastern Regional Meeting of the ACS and the secretary of the ACS Subcommittee on Chromatography and Separations Chemistry, through the HPLC 2016, 2018, & 2020 Symposium Organizing Committees, and by co-editing a special issue of the Journal of Chromatography A focused on chromatography and electrophoresis. In addition, he is a current executive committee member of the Chromatography Forum of Delaware Valley and regularly serves as a reviewer for several different separations-related journals.

Presentation 2: Unique Separation Needs of Biologicals: An Examination of Superficially Porous Particle Columns

Abstract: The landscape for new biological drug development continues to evolve in complexity. With biosimilars entering the market and originator products coming off patent, the competitive race for market dominance is reliant on:

· A deeper understanding of the drug product to produce a more comprehensive drug filing in order to delay or prevent market entrance by a competitor

·A more thorough characterization of an innovator product or proposed biosimilar in order to take full advantage of the regulatory pathways to rapid approval.

Pharmaceutical companies employ many orthogonal techniques and methodologies to better develop a complete picture of biopharmaceuticals, which are inherently more complex than small molecules. While not all separations involve HPLC, most do and would benefit from the unique characteristics of superficially porous particle columns. This presentation will walk through the biological drug development process, focusing on the unique separation needs of biologicals, including a conversation on intact and reduced mAb mass analysis by LC/MS. The presentation will also demonstrate a way to develop an understanding of the protein backbone via peptide mapping and glycosylation while emphasizing areas in the workflow where superficially porous particle columns with appropriate pore sizes offer a unique advantage.

About the Speaker:

Joseph L. Glajch is President and Principal Consultant of JLG AP Consulting LLC, which focuses on analytical and regulatory needs for the chemical and pharmaceutical industry. He received his AB in Chemistry at Cornell University and PhD in Analytical Chemistry at the University of Georgia under L.B. (Buck) Rogers. He has held technical and R&D management positions at DuPont, Bristol-Myers Squibb, Certus, and Momenta with emphasis on HPLC column and method development and pharmaceutical development and analysis. He has served as President and Program Chairman of the Analytical Division of the American Chemical Society and Program Chairman of the Gordon Conference on Analytical Chemistry. He has also served on the editorial advisory boards of Analytical Chemistry, the Journal of Chromatography, and LC/GC. He is a member of the USP Expert Committee on General Chemical Analysis as well as three other USP Expert Panels. Dr. Glajch has over 50 publications, is a co-author of three books, and has six patents on HPLC column materials and medical imaging agents.

Note to Drivers:The Triumph Brewing Company is about 5 miles from the EAS hotel.  There are parking garages/lots for people who want to drive and it is also an easy Uber ride.

50 people MAX limit for seating, anything above that will be standing room only.

Dinner and Beer/Wine will be served.

Contact Information:NJCG Chair: Ying Hu, PhD, e-mail: ying.hu@ascendiapharma.com; Cell: 201-961-5918



Meeting Logistics

where:

Triumph Brewing Company

138 Nassau Street

Princeton, New Jersey

08542

When:

November 18, 2019

Social: 5:00

Seminar: 5:30

Dinner: 6:30

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