E20: Intact and Top-Down Protein Characterization and Quantitation by Mass Spectrometry: Approaches for Pharmaceutical Drug Discovery, Development, and Bioanalysis

One-Day Course 
Date TBA; 8:30am – 5:00pm

Dr. John Kellie, GlaxoSmithKline, King of Prussia, PA
Dr. Wenying Jian, Janssen R&D, Spring House, PA

Intact and top-down protein analysis by mass spectrometry (MS) is poised to play an increasing role in pharmaceutical industry in the areas of drug discovery (proteomics, target characterization), development & manufacturing (antibody characterization, quality attributes, mass analysis), and pre-clinical / clinical study support (biomarkers & biotherapeutic monitoring for in-life studies). This course will provide a background in sample processing, analysis by MS, and data interpretation and analysis for the many applications of intact protein MS in pharmaceutical industry.

Industry or CRO employees interested applying top-down and intact protein MS, academic scholars wishing to use or learn more about the techniques, and government employees interested the analytical workflows.

1. Course Introduction
2. Front-End Sample Purification
a. Proteomic separations
b. Immuno-affinity purification
c. Sample cleanup prior to MS
d. LC and other online-separations coupled to MS
3. Intact and Top-Down Protein MS: The Raw Data
a. Spectral interpretation and troubleshooting
     b. Top-down protein characterization
c. Role of high-resolution MS
d. Instrument types and general MS parameter optimization
4. Data Processing and Analysis
a. Intact mass determination and mass variant analysis
b. Top-down proteomics workflows
c. Intact mass quantitation approaches
5. Application of Intact and Top-Down Protein MS Analysis (examples)
     a. Target characterization
b. Antibody characterization, quality attribute
c. Reagent characterization
d. Pre-clinical and clinical study support

Dr. John Kellie is currently an Associate GSK Fellow in the Bioanalysis, Immunogenicity, and Biomarkers group at GlaxoSmithKline. John received his B.S. in Biochemistry from Indiana University and his Ph.D. in Chemistry from Northwestern studying under Dr. Neil Kelleher. He was a Post-Doctoral Scientist at Eli Lilly and Company where he developed methods for intact protein quantitation of a Parkinson’s Disease biomarker from human brain tissue. At GSK, John utilizes mass spectrometry for development of novel bioanalytical methods for biotherapeutic & protein quantitation from pre-clinical and clinical samples.

Dr. Wenying Jian is currently a senior principal scientist of Janssen Research and Development, Johnson and Johnson.  She is leading a group to provide bioanalytical support, including large molecule therapeutics, biomarkers, and other novel scaffolds using LCMS.  Wenying received her B.S. in Pharmacy from Beijing Medical University and Ph.D. in Pharmacology from University of Pennsylvania under supervision of Dr. Ian Blair.   Wenying worked for Bristol-Myers Squibb and then Johnson and Johnson to support various bioanalytical activities in preclinical and clinical phases.   Wenying has published over 40 papers and book chapters and co-editor book of “Targeted biomarker quantitation by LC-MS”.  She currently serves on the editorial board of Journal of Pharmacological and Toxicological Methods and the board of Eastern Analytical Symposium. She is also a guest lecturer of Kean University.