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Integrating Viral Clearance into Your Process Development — A Case Study Using a Mixed‑Mode Chromatography Resin

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Session 1: November 12, 2019, 9:00–9:30 AM PST, 6:00–6:30 PM CET
Session 2: November 13, 2019, 7:00–7:30 AM CET, 2:00–2:30 PM SGT

Akunna Iheanacho, PhD, Director of Research and Development at Texcell – North America, Inc
Xuemei He, PhD, R&D Manager, Chromatograpy Media Chemistry at Bio-Rad Laboratories, Inc.
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Dr. Iheanacho and Dr. He will present a case study using a DOE approach with a mixed-mode chromatography resin to evaluate viral clearance. These studies can assist in defining the design space of a process step that targets product recovery and impurity removal.

Webinar Overview

Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. In this case study, we utilize a DOE approach to investigate the effect of buffer pH and conductivity on the removal of various product- and process-related impurities, including the minute virus of mice (MVM), by a mixed-mode chromatography resin, Nuvia aPrime 4A. Results from this study have offered insights on the interactions between the resin and MVM particles and the design space for the removal of this virus. Practical considerations for developing a mixed-mode chromatography process with effective overall impurity clearance will also be discussed in this webinar.

Speaker Bio

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Dr. Akunna Iheanacho is the Director of Research and Development at Texcell – North America, Inc. She supports novel assay development and virus purification efforts. She serves as a subject matter expert with over 15 years of experience in the purification, recovery, and formulation of proteins and biologics. Prior to Texcell, Dr. Iheanacho was a Senior Scientist at Paragon where she developed cGMP-ready processes for vaccines, AAV gene therapies, and reagents for diagnostics. She earned her PhD in Cellular and Molecular Physiology, MS in Chemistry, and BS in Biology.

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Dr. Xuemei He is the R&D Manager of Chromatography Media Chemistry at Bio-Rad Laboratories. She earned her PhD in Biological Chemistry and has over 20 years of experience in biomolecule separation and characterization. Her laboratory is concentrated on the development of chromatography media for process-scale production of biopharmaceuticals, with an emphasis on the removal of residual process- and product-related impurities during polishing stage and viral safety. She also provides application support on chromatography media screening, method development, and process optimization.

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