Chapter 28 - Virus removal in bioprocessing using charged media

Document Type

Book Chapter

Publication Date

2024

Department

Department of Chemical Engineering; Health Research Institute

Abstract

Viral removal has long been a key part of FDA-approved processes. Anion-exchange chromatography is commonly used to bind negatively charged viruses and separate them from therapeutic products. Each individual process must confirm that virus has been removed. This empirical determination of virus removal is now being pushed toward a more mechanistic understanding of virus removal. There are two key parts of a virus removal operation with charged media: the physicochemical attributes of the virus and proteins in solution, and the chromatography media. With new biophysical and computational tools, improvements are being made to provide a scientific basis for deviations in virus binding. New formats of ion exchange media are also improving the scale-up and reliability of virus removal mechanisms. Virus removal is becoming less of an empirical art and more of a science that will greatly improve the safety of biotherapeutics in the future.

Publication Title

Ion-Exchange Chromatography and Related Techniques

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