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Applied and Environmental Microbiology, August 2004, p. 4864-4871, Vol. 70, No. 8
0099-2240/04/$08.00+0     DOI: 10.1128/AEM.70.8.4864-4871.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Characterization of Coliphage PR772 and Evaluation of Its Use for Virus Filter Performance Testing

Scott Lute,¹ Hazel Aranha,^2, Denise Tremblay,³ Dehai Liang,⁴ Hans-W. Ackermann,^3,5 Benjamin Chu,⁴ Sylvain Moineau,^3,6 and Kurt Brorson^1*

Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda, Maryland 20892,¹ Scientific and Laboratory Services, Pall Corporation, Port Washington, New York 11050,² Departments of Chemistry, Materials Science and Engineering, and Biomedical Engineering, State University of New York, Stony Brook, New York 11794,⁴ Félix d'Hérelle Reference Center for Bacterial Viruses, Groupe de Recherche en Écologie Buccale, Faculté de Médecine Dentaire,³ Département de Biologie Médicale, Faculté de Médecine,⁵ Département de Biochimie et de Microbiologie, Faculté des Sciences et de Génie, Université Laval, Québec City, Québec, Canada G1K 7P4⁶

Received 21 January 2004/ Accepted 27 April 2004

Virus filtration is a key clearance unit operation in the manufacture of recombinant protein, monoclonal antibody, and plasma-derived biopharmaceuticals. Recently, a consensus has developed among filter manufacturers and end users about the desirability of a common nomenclature and a standardized test for classifying and identifying virus-retentive filters. The Parenteral Drug Association virus filter task force has chosen PR772 as the model bacteriophage to standardize nomenclature for large-pore-size virus-retentive filters (filters designed to retain viruses larger than 50 to 60 nm in size). Previously, the coliphage PR772 (Tectiviridae family) has been used in some filtration studies as a surrogate for mammalian viruses of around 50 to 60 nm. In this report, we describe specific properties of PR772 critical to the support of its use for the standardization of virus filters. The complete genomic sequence of virulent phage PR772 was determined. Its genome contains 14,946 bp with an overall G+C content of 48.3 mol%, and 32 open reading frames of at least 40 codons. Comparison of the PR772 nucleotide sequence with the genome of Tectiviridae family prototype phage PRD1 revealed 97.2% identity at the DNA level. By dynamic light-scattering analysis, its hydrodynamic diameter was measured as 82 ± 6 nm, consistent with use in testing large-virus-retentive filters. Finally, dynamic light-scattering analysis of PR772 preparations purified on CsCl gradients showed that the phage preparations are largely monodispersed. In summary, PR772 appears to be an appropriate model bacteriophage for standardization of nomenclature for larger-pore-size virus-retentive filters.

Present address: Wyeth Vaccines, Pearl River, NY 10965.