OPTIONAL COURSES
An additional registration fee is required to attend Course.

Optional Full-Day Course Sunday, October 14, 2007 9:00 am – 3:00 pm (An additional registration fee is required to attend Course)

Applications of CE to the Analysis of Protein Therapeutics
Chantal Felten and Oscar Salas-Solano, Genentech, Inc., South San Francisco, CA USA

This course will provide an overview of the fundamentals, modes and selected applications of CE as it applies to protein analysis in the biotechnology industry. The course will have a significant focus on practical industrial concerns in the application of CE in the analysis of protein therapeutics. The applications covered will feature know-how of current uses of CE in various areas of protein pharmaceutical development including formulation studies, process development and scale-up studies, product characterization and validated lot release and stability QC testing. The specific modes of CE that will be discussed include carbohydrate analysis, CZE, c-IEF and CE-SDS. The latter part of the course will focus on the interpretation of ICH Analytical Validation Guidelines as they apply to validation of CE methods for protein analysis and the use of these methods in routine cGMP lot release testing of marketed biologics. Finally, the advantages and limitations of the various CE methodologies in assessing the identity, purity and stability of biotechnology products will be discussed.

Optional Full-Day Course Thursday, October 18th, 2007 9:00 am – 3:00 pm (An additional registration fee is required to attend Course)

Method Optimization and Troubleshooting in Capillary Electrophoresis
Kevin Altria, GlaxoSmithKline R & D, Essex, United Kingdom

The fundamentals of CE will be briefly reviewed. An in-depth description of the correct practical operating procedures and how to successfully run a separation will be covered. The approaches to method optimization during method development will then be described paying particular attention to the influence of key operating parameters. Factors affecting routine short and long term operation will be presented which include aspects such as buffer depletion, capillary conditioning and sample diluent effects. The approaches to the optimization of precision in quantitative analysis such as use of internal standards and optimal injection procedures will be detailed. The possible mechanisms to improve detector sensitivity such as capillary modifications and buffer selection will then be covered. Good working practices such as dedication and storage of capillaries, and avoidance of carryover effects will be described. Finally detailed focus will be paid to systematic troubleshooting approaches in CE and a listing of fixes to commonly encountered problems will be provided. This course will be interactive with the participants who can bring their non-confidential separation problems along for discussion.