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Clearance of minute virus of mice by flocculation and microfiltration

Clearance of minute virus of mice by flocculation and microfiltration Clearance of minute virus of mice (MVM) from CHO cell suspensions by flocculation and microfiltration has been investigated. MVM is a parvovirus that is recommended by the U.S. Food and Drug Administration for validating clearance of parvoviruses. The feed streams were flocculated using a cationic polyelectrolyte. Virus clearance in excess of 10,000‐fold was obtained in the bulk permeate for flocculated feeds streams. However, the level of clearance was only about 10‐ to 100‐fold for unflocculated feed streams. The results suggest that virus clearance involves interactions between the MVM particles, the cationic polyelectrolyte, and the CHO cells present. Validating virus clearance is a major concern in the biotechnology industry. New unit operations are frequently added to the purification train simply to validate virus clearance. However, many of these unit operations are less effective at validating clearance of nonenveloped viruses. Validating clearance of parvoviruses is often particularly problematic as they are nonenveloped and the virus particles are small (18 to 24 nm), making physical removal difficult. The results obtained herein indicate that addition of the cationic polyelectrolyte not only results in significant clearance of MVM but also leads to an increase in permeate flux. © 2004 Wiley Periodicals, Inc. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Biotechnology and Bioengineering Wiley

Clearance of minute virus of mice by flocculation and microfiltration

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References (42)

Publisher
Wiley
Copyright
Copyright © 2004 Wiley Periodicals, Inc., A Wiley Company
ISSN
0006-3592
eISSN
1097-0290
DOI
10.1002/bit.10889
pmid
15137071
Publisher site
See Article on Publisher Site

Abstract

Clearance of minute virus of mice (MVM) from CHO cell suspensions by flocculation and microfiltration has been investigated. MVM is a parvovirus that is recommended by the U.S. Food and Drug Administration for validating clearance of parvoviruses. The feed streams were flocculated using a cationic polyelectrolyte. Virus clearance in excess of 10,000‐fold was obtained in the bulk permeate for flocculated feeds streams. However, the level of clearance was only about 10‐ to 100‐fold for unflocculated feed streams. The results suggest that virus clearance involves interactions between the MVM particles, the cationic polyelectrolyte, and the CHO cells present. Validating virus clearance is a major concern in the biotechnology industry. New unit operations are frequently added to the purification train simply to validate virus clearance. However, many of these unit operations are less effective at validating clearance of nonenveloped viruses. Validating clearance of parvoviruses is often particularly problematic as they are nonenveloped and the virus particles are small (18 to 24 nm), making physical removal difficult. The results obtained herein indicate that addition of the cationic polyelectrolyte not only results in significant clearance of MVM but also leads to an increase in permeate flux. © 2004 Wiley Periodicals, Inc.

Journal

Biotechnology and BioengineeringWiley

Published: Jun 20, 2004

Keywords: flocculation; microfiltration; virus clearance; minute virus of mice; Chinese hamster ovary cells

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