Here in Part 1, we will introduce the topic by presenting results from an intercompany study carried out by an international team of 12 laboratories from 10 independent companies in the US, Switzerland and Germany. The results of this study demonstrated that CZE for charge heterogeneity profiling of mAbs is precise, robust, sensitive and provided superior resolution.
This demonstrates that it is suitable for use in a GMP environment. The method is applicable to proteins with a broad range of isoelectric point (pI) and, therefore, is generically applicable for mAbs. CZE appears as a new powerful platform technology for the charge heterogeneity testing of antibodies in the pharmaceutical industry.
Moderator: Laura Bush, Editorial Director, LCGC Presenter: Dr. Bernd Moritz, Hoffmann-La Roche, Pharmaceuticals Division, Basel Switzerland
In this second webcast in the series, a case study from MSD in the Netherlands will be presented in which CZE is also optimized and validated. The reasons for choosing the assay will be described, including fast method development, simple workflow, equivalent or better performance than high-performance ion-exchange (HPIEX) and imaged capillary isoelectric focusing (icIEF), as well as standardization on the same capillary electrophoresis (CE) platform as used for CE-SDS analysis.
Moderator: Alasdair Matheson, Editor in Chief, LCGC Europe Speakers: Dr. Joop Waterval, Principal Scientist, Merck Sharp & Dohme Tijmen Verweij,Scientist, Merck Sharp & Dohme
In the final webcast in the series, we present a case study from Novartis that compared a CZE method with icIEF/cIEF and CEX. The CZE method was fast and provided high resolution and, unlike imaged cIEF and CEX, does not require sample specific modifications for mAbs. The presented work resulted in the transfer of the CZE method to QC.
Moderator: Alasdair Matheson, Editor in Chief, LCGC Europe Speaker: Dr. Marc Hassel, Head of Phys. Chem. Analytics Early Phase Development, Novartis Pharma AG, Basel, Switzerland