Joint Meeting with North Jersey Discussion Group
About This Sponsored Event
To register and pay for the meeting, visit http://www.njcg.org/upcoming_meeting/registration
Cost:
Professionals: $10
Full-time Student/Retired/Unemployed
Presentation 1: Increasing Method Throughput with Ultra-High
Pressure Liquid Chromatography
James Grinias, Ph.D., Assistant Professor
Department of Chemistry and Biochemistry, Rowan University
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.
Presentation 2: Unique Separation Needs of Biologicals: An
Examination of Superficially Porous Particle Columns
Joseph L. Glajch, Ph.D., President
JLG AP Consulting LLC
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.