10 Minute Charge Heterogeneity Analysis for Development and Quality Control of Biopharmaceuticals
- Broadcast Date:
Tuesday, November 12, 2013
10 AM PST, 1 PM EST
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Determination of protein isoelectric points and charge isoforms are critical steps in protein characterization and biopharmaceutical development. Charge variants commonly occur as a result of posttranslational modification including glycosylation, glycation of lysine residues, amidation, sialylation, and oxidation. These changes can affect biological activity, patient safety, and drug stability.
Automated methods for charge heterogeneity detection such as imaged capillary isolectric focusing (icIEF) have been widely adopted by the biopharma industry. These techniques provide high-resolution charge variant separation and allow more rapid method development while minimizing start up time, manual processes and results variability.
In this webinar Scott Mack, Senior Scientist, ProteinSimple, will present an overview of imaged capillary isoelectric focusing ( icIEF) and describe fast and easy development of a robust charge heterogeneity assay for biotherapeutics. Carrie L. Anderson, Senior Scientist, Vaccine Analytical Development, Merck & Co. will present the wide range of applications for icIEF in biopharmaceutical development and demonstrate how icIEF increases the efficiency of process and formulation development. Karan Shah, Senior Research Associate, Immunogen will review the challenges of analysing antibody drug conjugates (ADC) and present how icIEF allows them to monitor both the charge heterogeneity profile and quantitate the amount of unconjugated antibody present in a ADC sample.
What You Will Learn
- How a single instrument platform can be implemented across the entire pharmaceutical process, from formulation development and optimization, to commercial quality control(QC) release and stability activities
- How free solution IEF in a capillary column (cIEF) can detect focused protein zones in 10 minutes
- How the ProteinSimple iCE system can resolve deamidation, C-terminal lysines, sialylation, oxidation, glycoslyation glycation, and any other change to the protein that will
- result in a change to the pI of the protein
Who Should Attend
- Protein and peptide biochemists
- Monoclonal antibody therapeutics developers
- Quality assurance/quality control scientists
- Therapeutic protein manufacturing process development scientists
- Formulation scientists
A live Q&A session will follow the presentations,
offering you a chance to pose questions to our expert panelists.