An Introduction to Stress Testing Techniques for Protein Pharmaceuticals - Jan 25-26, 2005 - San Diego, CA

An Introduction to Stress Testing Techniques for Protein Pharmaceuticals
Jan 25-26, 2005 - San Diego, CA
Sheraton San Diego Hotel and Marina
Event Overview

The stress testing and forced degradation of proteins is a highly complex field with little regulatory guidance and few industry standards. To meet this information need and to bring stress testing peers together for information exchange and solution-finding purposes, we designed an event that provides a basic introduction to the key routine and advanced stability-indicating techniques.
Due to the overwhelming success of our July 2004 event, we are happy to offer our ?An Introduction to Stress Testing Protein Pharmaceuticals? seminar again in a new expanded format. With two offerings, November 15-16, 2004, Bethesda, MD and January 25-26, 2005, San Diego, this seminar introduces each technology and shows its application to biopharmaceutical products. Those new to the field, or wanting a refresher course on protein stability testing, would find this seminar to be particularly valuable.
Expanded to include even more interactive breakout sessions, this two day seminar addresses the theoretical and practical aspects of the following categories of techniques:
Seminar Day One:
Chromatographic Methods (SEC, RP, IEX, HIC HPLC with UV and fluorescent detection)
Physical Methods (AUC, light scattering, FTIR, DSC)
Spectroscopic Methods (MALDI, ESI, other mass spec) Seminar Day Two
Electrophoretic Methods (PAGE, IEF, CE)
Immunological Methods (ELISA, western blots, SPR)
Activity Methods (in vivo and in vitro bioassays)
Seminar Day Two:
Electrophoretic Methods (PAGE, IEF, CE)
Immunological Methods (ELISA, western blots, SPR)
Activity Methods (in vivo and in vitro bioassays)
Why you should attend

Objectives:
To examine the theoretical and practical aspects of the following categories
of stress testing techniques for proteins:
Chromatographic Methods (SEC, RP, IEX, HIC HPLC with UV and Fluorescent Detection)
Physical Methods (AUC, Light Scattering, FTIR, DSC)
Spectroscopic Methods (MALDI, ESI, Other Mass Spec)
Electrophoretic Methods (PAGE, IEF, CE)
Immunological Methods (ELISA, Western Blots, SPR)
Activity Methods (In Vivo and In Vitro Bioassays)
PLUS:
We address the Regulatory and Quality Considerations for Biopharmaceutical
Product Development Stability and Formulation Studies
Including panel sessions and specially designed
break-outs covering:
Types of Stress Conditions and Experimental Approach
Validation of Stability-Indicating Techniques
Pre-Formulation Testing: Selection Process for Excipients and Stability
Excipient Formulation and Degradation Pathways