10 Minute Charge Heterogeneity Analysis for Development and Quality Control of Biopharmaceuticals

• Broadcast Date: Wednesday, June 19, 2013
• Time: 1:00 pm ET, 10:00 am PT

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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 post-translational 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 review current charge heterogeneity techniques and describe development of a robust charge heterogeneity assay for the characterization and quality control of biotherapeutics. The assay can be used to standardize platform methods across product development and QC, eliminating the need for product-specific method development. Stan Kwok, Ph.D., senior scientist, Seattle Genetics, will present an overview of biotherapeutic formulation development, analytical methods for formulation screening, and the development of a high-throughput charge heterogeneity method to accelerate formulation development.

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.

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