Date is TBA; 8:30am – 5:00pm
Dr. Michael W. Dong, MWD Consulting, Foster City, CA
This intermediate 1-day workshop will provide the analytical scientist with a clearer understanding and a solid working knowledge on the best practices in method development, HPLC operation/troubleshooting, and other applications of modern HPLC and UHPLC including characterization/QC of recombinant biologics.
Modern HPLC/UHPLC for Practicing Scientists 1: Fundamentals and Pharmaceutical Applications is the first part of this two-day course. Part 1 and 2 can be combined as a two-day course; a discount will be offered over separately registering for the two one-day courses. (click here for Part 1 course description)
WHO SHOULD ATTEND
Analysts, scientists, researchers, and managers in pharmaceutical and other industries who want to get an updated overview of fundamentals and best practice of modern HPLC/UHPLC in pharmaceutical analysis and other applications including HPLC method development, operation, and troubleshooting. A basic understanding of chemistry and HPLC with some hands-on experience is assumed.
1. Other HPLC Applications including Recombinant Biologics
a. Characterization and QC of recombinant biologics (Monoclonal Antibodies)
b. Food: sugars, fats, organic acids, and additives.
c. Environmental: US EPA methods, pesticides, and PAHs.
d. Chemical: GPC, plastics, and ion-chromatography.
e. Bioseparations and life sciences: proteins, peptides, peptide mapping, amino acids, oligonucleotides, nuclei acids, and PCR products.
2. UHPLC: Concept, Perspectives, Practice and Potential Issues
a. Overview and perspectives, UHPLC concepts (the need for high pressure, void volume, peak volume, instrumental bandwidth), UV flow cell design, dwell volume
b. Benefits and case studies: very fast separations with good resolution, very high resolution analysis of complex samples, facilitating rapid method development, flexibility to customize resolution
c. Potential issues and how to mitigate (viscous heating, operating nuances, compatibility to existing methods, injection precision, detector sensitivity vs. mixing volumes), method translation from HPLC to UHPLC and vice versa using geometric scaling, how to transition from HPLC to UHPLC, end-fittings
3. HPLC Method Development and Validation
a. Tradition strategy for HPLC method development
b. 3-pronged template approach for rapid method development
c. Use of a universal generic gradient method for assay of multiple NCEs and stability-indicating assays with simple adjustments
d. A brief overview of method validation
4. HPLC Operation and Troubleshooting
a. Mobile phase and sample preparation and best practice in HPLC operation
b. Problem diagnosis and troubleshooting guide with case studies
c. Diagnosing and solving problems (pressure, baseline, peak, data performance)
ABOUT THE INSTRUCTOR
Dr. Michael W. Dong is a principal consultant in MWD Consulting focusing on consulting and training services on HPLC/UHPLC, pharmaceutical analysis, and drug quality. He was formerly Senior Scientist in Analytical Chemistry and Quality Control at Genentech, Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems / Perkin-Elmer. He holds a Ph.D. in Analytical Chemistry from the City University of New York, and a certificate in Biotechnology from U. C. Santa Cruz. He has 100+ publications including a bestselling book on chromatography (Modern HPLC for Practicing Scientists, Wiley). He is an editorial advisory board member of LCGC magazine, American Pharmaceutical Review, and Chinese American Chromatography Association.