WORKSHOP DESCRIPTIONS

Method Validation and Troubleshooting [Leader: TBD]

This session will compromise of a series of short presentations on experiences encountered during the routine application, validation and transfer of CE methods. This will cover both analysis of small molecule pharmaceuticals and biopharmaceuticals. Details of the typical validation protocol content that are employed will be detailed. The figures of merit for validation criteria routinely obtained will be discussed and illustrated - including precision, accuracy, linearity. Experiences of method transfer, between analysts, laboratories and sites will be presented and described. In particular operational difficulties and problem solutions will be highlighted. The remainder of the session will be open for all attendees to raise questions for the expert panel. In addition attendees will be encouraged to share learning’s for their experiences in routine method operation, and method validation and transfer.

Intercompany Collaboration: Rise of the cIEF [Leader: Brian K. Nunnally, Wyeth]

The use of CE for the characterization and analysis of Biomolecules is less well routinely established. A project team was formed from a number of interested Biopharmaceutical companies to conduct a cross-company collaboration exercise. A CE-SDS method was tested across multiple companies using a variety of different instruments. The results from this exercise were published in Chromatographia to highlight the performance that can be obtained for a well controlled CE method in biopharmaceutical analysis laboratories.

The next collaboration will be focused on Capillary IsoElectric Focusing (cIEF). Some results of the executed protocol will be discussed.