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Managing Aggregates in Your Monoclonal Antibody (mAb) Process

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Product Aggregation in Bioprocessing: Origins, Prevention, and Removal

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Aggregates in mAb therapeutics pose a risk to patients. Are you considering how best to manage and remove aggregates across your template?

In this 6-part video series, watch our experts discuss which steps in the biomanufacturing process are involved in the formation or removal of aggregates and industry-leading approaches.

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Can aggregates in protein be detected by the naked eye?
Is it possible that proteins refold after a bubbling event, or is this definitely an irreversible aggregation event?
Introduction to Product Aggregation
How do you calculate the number of pump passes in a Tangential Flow Filtration (TFF) operation?
What is the cavitation phenomenon exactly and how does it cause protein aggregation?
How precisely does aggregate formation impact on filtration for viral clearance?

Overview

Herb Lutz, Global Consultant, discusses the formation of protein aggregates and their regulatory importance. An overview of methods and technologies will be reviewed for managing or removing aggregates from your mAb process including upstream, chromatography, virus filtration, ultrafiltration/diafiltration (UF/DF), and final formulation.

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Upstream

Michael A. Cunningham, Ph.D., Associate Director, Applications Engineering, focuses on how upstream unit operations including clone selection, process optimization such as nutrient optimization and oxygen availability can impact monoclonal antibody aggregation in your process.

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Affinity and Ion Exchange Chromatography

Santosh B. Rahane, Ph.D, Senior Research Scientist, addresses the removal of mAb aggregates from monomeric products using protein A affinity, cation exchange (CEX), and anion exchange (AEX) chromatography steps in both bind/elute and flow through modes.

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Virus Filtration

David Bohonak, PhD, Senior Applications Engineer, speaks about the effects of protein aggregation on virus filtration. The types of aggregates, considerations for viral clearance studies, and the use of adsorptive prefiltration for aggregate removal are discussed.

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Ultrafiltration/Diafiltration (UF/DF)

Emily Peterson, Senior Biomanufacturing Engineer, discusses how careful selection of operation conditions and Tangential Flow Filtration (TFF) system design impacts aggregate formation within the UF/DF process.

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Final Formulation

Christoph Korpus, Liquid Formulation Stability, focuses on monoclonal antibody aggregation highlighting liquid formulation stability through the use of excipients and the importance of high quality chemicals.

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