Abstract
Membrane-based separation processes are routinely used for virus removal and virus purification. In the manufacture of protein-based biopharmaceuticals, validation of virus clearance is critical. Viruses represent a possible contaminant. However, recovery and purification of virus particles is essential for the large-scale production of virus vectors for gene therapy applications and viral vaccines. Here virus particles represent the therapeutic of interest. Recovery and purification of virus particles is particularly challenging given the fragility and complexity of these particles compared to therapeutic proteins. Currently, there are three membrane-based unit operations that are frequently used for virus removal and purification operations: virus filtration, membrane adsorber-based chromatography, and tangential flow filtration. These unit operations are the topic of this chapter. Given the numerous advantages of membrane-based unit operations such as scalability and gentle processing conditions, development of new membranes and modes of operation continues to grow.
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