E22: Characterization of Biologics by HPLC, CE, and Mass Spectrometry

One-Day Course
Date / time to be announced; 8:30am – 5:00pm

Dr. Li Tao, Bristol-Myers Squibb
Dr. Ming Zeng, Bristol-Myers Squibb

This short course will provide an overview of fundamentals and current practice of biologics analysis supporting process development in pharmaceutical industry.  Critical concepts, general strategies, and regulatory considerations that guide the applications of various technics, as well as their capabilities and limitation will be covered comprehensively.  This short course will focus on molecular attributes analysis for the major analytical development activities, such as molecular profiling, variants analysis, forced degradation studies, critical quality attribute identification, structure-function relationship, analytical control strategies, etc.

Industry attendees interested in learning the current strategies and practices in biologics analysis supporting drug discovery and development.  Academic attendees such as graduate students or anyone who are considering a career path in the pharmaceutical industry, especially in the discovery and development of protein therapeutics.

1. Promises and Challenges for Biologics
2. Analytical Development and Process Development for Biologics
3. Basics of Capillary Electrophoresis (CE), HPLC, and Mass Spectrometry (MS)
4. Application of CE, HPLC, and MS in the Biologics Development and Case Studies
5. Conclusions

Dr. Li Tao
is currently Director, Biophysical and Biochemical Characterization Center of Excellence, in the Department of Biologics Development, Bristol-Myers Squibb Company, where he has been working for the last 22 years.  Over his tenure at BMS, he has been responsible for the characterization of biologics in development pipeline. He leads the mass spectrometry group for protein therapeutics development and served as the co-chair of biologics comparability council responsible for the design and execution of comparability studies supporting process development and commercial process change.  He also led the integrated CMC development team for Opdivo from Ph I to Ph III.  His previous experience includes expression, purification, and characterization of recombinant proteins in support of therapeutic target identification, drug screening, and structural biology studies.  Li received his BS degree from University of Science and Technology of China, and his Ph.D. from the University of Florida.

Dr. Ming Zeng