June 18, 2015
11 am to 12 pm EDT

Sponsored by

Webinar Description:

Determination of isoelectric points and charge isoforms are critical steps in protein characterization for biopharmaceutical and vaccine development. Charge variants or heterogeneity commonly occurs as a result of post-translational modification including glycosylation, deamidation, sialylation and oxidation. These changes can affect biological activity and drug stability. In this webinar, we will present examples of method development and transfer for Charge heterogeneity analysis of biopharmaceutical products using iCE platform focusing on specific requirement of a QC environment. We will also provide a brief overview on robust method development on iCE3.

Learning Objectives:

• How the ProteinSimple iCE system can resolve charge variants due to deamidation, C-terminal lysines, sialylation, oxidation, glycosylation, and any other change to the protein that will result in a change in pI of the protein
• Understanding the requirements and of the QC environment
• How the iCE system can be implemented across the entire pharmaceutical process, from formulation development and optimization, to commercial quality control (QC) release and stability activities

Speakers:

Joan Garrison

Scientist, QC Method Transfer

Cook Pharmica LLC

Bio: Joan Garrison is a QC Method Transfer Scientist at Cook Pharmica. Her current focus is on implementation of iCE3 platform for characterization and identification of various biopharmaceutical products, including mAbs, ADCs and fusion proteins. She has extensive experience in Capillary Electrophoresis (CE) and method development for charge heterogeneity analysis using CE methods. She previously worked in Bioanalytical services group at Covance and GR&D analytical services at Mead Johnson Nutrition.

Presentation: The ProteinSimple iCE3TM System enables reproducible, high throughput, free solution isoelectric focusing (IEF) in a capillary column (cIEF) for detection and quantification of focused amphoteric molecules such as proteins and peptides. Whole-column UV absorption detection is performed every 30 seconds for real time monitoring of molecules focusing at their isoelectric points (pIs). This unique technology combines the high resolution of traditional gel IEF with the advantages of quantitation and automation found in column based separations while eliminating the need for a mobilization step. The application of icIEF is rapidly growing in the quality control (QC) laboratory due to the enhanced throughput of confirmatory identification and quantification of amphoteric molecules in the QC laboratory. Each year more methods are transferred from traditional slab gel IEF assays to the ProteinSimple iCETM platform for application in the QC laboratory. Additionally, many companies purchase materials that have been fully characterized using the iCE platform. However; in many cases the companies have the associated electropherogram but they don’t have the method conditions. This situation can be challenging, trying to transition these methods in to the CMO/CRO laboratories. This presentation will describe several common problems and solutions associated with iCETM development/ method transfer in the QC laboratory.

Scott Mack

Senior Scientist

ProteinSimple

Bio: Scott Mack is a Senior Development Scientist with ProteinSimple currently supporting analysts utilizing imaged capillary electrophoresis (iCE, Simple Western) and Microflow imaging (MFI) technology for the characterization of protein therapeutics. Since 2001, Scott has held various posts, focusing on assay development for the fields of cellular, proteomic, and genomic analysis. He has extensive experience in system development for capillary electrophoresis (CE) for both conventional photometric and advanced mass spectrometric detection.

Presentation: Since its introduction, iCE has become a preferred method for charge heterogeneity analysis by the biopharmaceutical industry, generating critical data for regulatory submissions and manufacturing lot releases. The simple and robust technique of Imaged whole capillary electrophoresis provides critical information about the identity, purity, stability, and post-translational modifications of therapeutic biologics. In this presentation, we will focus on the important analyte and instrument-based considerations crucial to achieving the maximum performance for the iCE. By reviewing the mechanics of isoelectric focusing and the critical parameters in developing robust separations the presenter will provide a step-by-step guidance for optimizing separations.

Cost: No cost