Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies

References

1. 1.↵
   FDA; ICH. Guidance for Industry. Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, Center for Biologiscs Evaluation and Research (CBER): Rockville, MD, 1998.
2. 2.↵
   The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit, Committee for Proprietary Medicinal Products (CPMP). Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products, 2009. CPMP/BWP/398498/2005.
3. 3.↵
   FDA. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. U.S. Department of Health and Human Services, FDA, CBER: Rockville, MD, 1997.
4. 4.↵
   1. Zhou J. X.,
   2. Solamo F.,
   3. Hong T.,
   4. Shearer M.,
   5. Tressel T.

   Viral clearance using disposable systems in monoclonal antibody commercial downstream processing. Biotechnol. Bioeng. 2008, 100 (3), 488–496.

   OpenUrlPubMed
5. 5.↵
   1. Shukla A. A.,
   2. Etzel M. R.,
   3. Gadam S

   1. Kundu A.,
   2. Reindel K.

   Evaluation of Viral Clearance in Purification Processes. In Process Scale Bioseparations for the Biopharmaceutical Industry, Shukla A. A., Etzel M. R., Gadam S, Eds.; CRC Press: Boca Raton, FL, 2006; pp 419–448.
6. 6.↵
   1. Carter J.,
   2. Lutz H.

   An overview of viral filtration in biopharmaceutical manufacturing. Eur. J. Parenter. Sci. 2002, 7(3), 72–78.

   OpenUrl
7. 7.↵
   1. Meltzer T. H.,
   2. Jornitz M. W.

   1. Levy R. V.,
   2. Phillips M. W.,
   3. Lutz H.

   Filtration and the Removal of Viruses from Biopharmaceuticals. In Filtration in the Biopharmaceutical Industry, Meltzer T. H., Jornitz M. W., Eds.; Dekker: New York, 1998; pp 619–646.
8. 8.↵
   1. Flickinger M. C.

   1. Miesegaes G.,
   2. Lute S.,
   3. Aranha H.,
   4. Brorson K.,
   5. Flickinger M. C.

   Virus Retentive Filters. In Encyclopedia of Industrial Biotechnology, Flickinger M. C., Ed.; John Wiley & Sons, Inc.: New York, 2009.
9. 9.↵
   1. Miesegaes G.,
   2. Lute S.,
   3. Dement-Brown J.,
   4. Kaushal S.,
   5. Strauss D.,
   6. Chen D.,
   7. Brorson K.

   A survey of quality attributes of virus spike preparations used in clearance studies. PDA J. Pharm. Sci. Technol. 2012, 66(5), 420–433.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Garnick R. L.

    Experience with viral contamination in cell culture. Dev. Biol. Stand. 1996, 88, 49–56.

    OpenUrlPubMed
11. 11.↵
    1. Miesegaes G.,
    2. Bailey M.,
    3. Willkommen H.,
    4. Chen Q.,
    5. Roush D.,
    6. Blumel J.,
    7. Brorson K.

    Proceedings of the 2009 Viral Clearance Symposium. Dev Biol (Basel) 2010, 133, 3–101.

    OpenUrlPubMed
12. 12.↵
    PDA Technical Report No. 41: Virus Filtration. Parenteral Drug Association: Bethesda, MD, 2008.
13. 13.↵
    1. Brorson K.,
    2. Krejci S.,
    3. Lee K.,
    4. Hamilton E.,
    5. Stein K.,
    6. Xu Y.

    Bracketed generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins. Biotechnol. Bioeng. 2003, 82(3), 321–329.

    OpenUrlCrossRefPubMed
14. 14.↵
    1. Curtis S.,
    2. Lee K.,
    3. Blank G. S.,
    4. Brorson K.,
    5. Xu Y.

    Generic/matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mode. Biotechnol. Bioeng. 2003, 84(2), 179–186.

    OpenUrlPubMed
15. 15.↵
    1. Willkommen H.,
    2. Blümel J.,
    3. Brorson K.,
    4. Chen D.,
    5. Chen Q.,
    6. Gröner A.,
    7. Kreil T. R.,
    8. Robertson J. S.,
    9. Ruffing M.,
    10. Ruiz S.

    Meeting Report: PDA Virus and TSE Safety Forum. PDA J. Pharm. Sci. Technol. 2013, 67(2), 81–97.

    OpenUrlAbstract/FREE Full Text
16. 16.↵
    1. Willkommen H.,
    2. Blümel J.,
    3. Brorson K.,
    4. Chen D.,
    5. Chen Q.,
    6. Gröner A.,
    7. Kreil T. R.,
    8. Robertson J. S.,
    9. Ruffing M.,
    10. Ruiz S.

    Meeting report—workshop on virus removal by filtration: trends and new developments. PDA J. Pharm. Sci. Technol. 2013, 67(2), 98–104.

    OpenUrlAbstract/FREE Full Text
17. 17.↵
    1. Bakhshayeshi M.,
    2. Jackson N.,
    3. Kuriyel R.,
    4. Mehta A.,
    5. van Reis R.,
    6. Zydney A. L.

    Use of confocal scanning laser microscopy to study virus retention during virus filtration. J. Membr. Sci. 2011, 379(1–2), 260–267.

    OpenUrl
18. 18.↵
    1. Phillips M. W.,
    2. DiLeo A. J.

    A validatible porosimetric technique for verifying the integrity of virus-retentive membranes. Biologicals 1996, 24(3), 243–253.

    OpenUrlCrossRefPubMed
19. 19.↵
    1. Peinador R. I.,
    2. Calvo J. I.,
    3. ToVinh K.,
    4. Thom V.,
    5. Prádanos P.,
    6. Hernández A.

    Liquid–liquid displacement porosimetry for the characterization of virus retentive membranes. J. Membr. Sci. 2011, 372(1-2), 366–372.

    OpenUrl
20. 20.↵
    1. Bolton G.,
    2. Cormier J.,
    3. Krishnan M.,
    4. Lewnard J.,
    5. Lutz H.

    Integrity testing of normal flow parvovirus filters using air-liquid based tests. Bioprocessing J. 2006, 5(1), 50.

    OpenUrl
21. 21.↵
    1. Giglia S.,
    2. Krishnan M.

    High sensitivity binary gas integrity test for membrane filters. J. Membr. Sci. 2008, 323(1), 60–66.

    OpenUrl
22. 22.↵
    1. Hirasaki T.,
    2. Noda T.,
    3. Nakano H.,
    4. Ishizaki Y.,
    5. Manabe S.,
    6. Yamamoto N.

    Mechanism of removing Japanese encephalitis virus (JEV) and gold particles using cuprammonium regenerated cellulose hollow fiber (i-BMM or BMM) from aqueous solution containing protein. Polym. J. 1994, 26(11), 1244–1256.

    OpenUrl
23. 23.↵
    1. Bakhshayeshi M.,
    2. Kanani D. M.,
    3. Mehta A.,
    4. van Reis R.,
    5. Kuriyel R.,
    6. Jackson N.,
    7. Zydney A. L.

    Dextran sieving test for characterization of virus filtration membranes. J. Membr. Sci. 2011, 379(1), 239–248.

    OpenUrl
24. 24.↵
    1. Zachariah M. R.,
    2. Tarlov M. J.,
    3. Etzel M.,
    4. Brorson K.

    1. Lute S.,
    2. Riordan W.,
    3. Pease L. F. III.,
    4. Tsai D.-H.,
    5. Levy R.,
    6. Haque M.,
    7. Martin J.,
    8. Moroe I.,
    9. Sato T.,
    10. Morgan M.,
    11. Krishnan M.,
    12. Campbell J.,
    13. Genest P.,
    14. Dolan S.,
    15. Tarrach K.,
    16. Meyer A.

    ; PDA Virus Filter Task Force; Zachariah M. R., Tarlov M. J., Etzel M., Brorson K. A consensus rating method for small virus-retentive filters. I. Method development. PDA J. Pharm. Sci. Technol. 2008, 62(5), 318–333.

    OpenUrlAbstract/FREE Full Text
25. 25.↵
    1. Grant D. C.,
    2. Liu B. Y. H.

    Sieving capture of liquidborne particles by microporous membrane filtration media. Particle & Particle Systems Characterization 1991, 8(1–4), 142–150.

    OpenUrl
26. 26.↵
    1. DiLeo A. J.,
    2. Vacante D. A.,
    3. Deane E. F.

    Size exclusion removal of model mammalian viruses using a unique membrane system, Part I: Membrane qualification. Biologicals 1993, 21(3), 275–286.

    OpenUrlPubMed
27. 27.↵
    1. Grant D. C.,
    2. Liu B. Y. H.,
    3. Fisher W. G.,
    4. Bowling R. A.

    Particle capture mechanisms in gases and liquids: an analysis of operative mechanisms in membrane/fibrous filters. J. Environ. Sci. 1989, 32(4), 43–51.

    OpenUrl
28. 28.↵
    FDA, U.S. Department of Health and Human Services. Guidance for Industry. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, 2004.
29. 29.↵
    ASTM F838–05 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, 2005.
30. 30.↵
    1. Wurm F. M.

    Production of recombinant protein therapeutics in cultivated mammalian cells. Nat. Biotechnol. 2004, 22(11), 1393–1398.

    OpenUrlCrossRefPubMedWeb of Science
31. 31.↵
    1. Berting A.,
    2. Farcet M. R.,
    3. Kreil T. R.

    Virus susceptibility of Chinese hamster ovary (CHO) cells and detection of viral contaminations by adventitious agent testing. Biotechnol. Bioeng. 2010, 106(4), 598–607.

    OpenUrlPubMed
32. 32.↵
    1. Garnick R. L.

    Raw materials as a source of contamination in large-scale cell culture. Dev. Biol. Stand. 1998, 93, 21–29.

    OpenUrlPubMedWeb of Science
33. 33.↵
    1. Nims R. W.

    Detection of adventitious viruses in biologicals—a rare occurrence. Dev. Biol. (Basel) 2006, 123, 153–64, discussion 183–197.

    OpenUrlPubMed
34. 34.↵
    1. Oehmig A.,
    2. Buttner M.,
    3. Weiland F.,
    4. Werz W.,
    5. Bergemann K.,
    6. Pfaff E.

    Identification of a calicivirus isolate of unknown origin. J. Gen. Virol. 2003, 84(10), 2837–2845.

    OpenUrlAbstract/FREE Full Text
35. 35.↵
    1. Onions D.

    Animal virus contaminants of biotechnology products. Dev. Biol. (Basel) 2004, 118, 155–163.

    OpenUrlPubMed
36. 36.↵
    1. Moody M.,
    2. Alves W.,
    3. Varghese J.,
    4. Khan F.

    Mouse minute virus (MMV) contamination—a case study: detection, root cause determination, and corrective actions. PDA J. Pharm. Sci. Technol. 2011, 65(6), 580–588.

    OpenUrlAbstract/FREE Full Text
37. 37.↵
    1. Victoria J. G.,
    2. Wang C.,
    3. Jones M. S.,
    4. Jaing C.,
    5. McLoughlin K.,
    6. Gardner S.,
    7. Delwart E. L.

    Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J. Virol. 2010, 84(12), 6033–6040.

    OpenUrlAbstract/FREE Full Text
38. 38.↵
    1. Tidona C. A.,
    2. Darai G.

    The Springer Index of Viruses, 2nd ed.; Springer: New York, 2011.
39. 39.↵
    PDA Technical Report No. 47: Preparation of Virus Spikes Used for Virus Clearance Studies. Parenteral Drug Association: Bethesda, MD, 2010.
40. 40.↵
    1. Cabatingan M.

    Impact of virus stock quality on virus filter validation. BioProcess Int. 2005, 3(10), S39–S43.

    OpenUrl
41. 41.↵
    1. Khan N. Z.,
    2. Parrella J. J.,
    3. Genest P. W.,
    4. Colman M. S.

    Filter preconditioning enables representative scaled-down modelling of filter capacity and viral clearance by mitigating the impact of virus spike impurities. Biotechnol. Appl. Biochem. 2009, 52(4), 293–301.

    OpenUrlPubMed
42. 42.↵
    1. Bolton G.,
    2. Cabatingan M.,
    3. Rubino M.,
    4. Lute S.,
    5. Brorson K.,
    6. Bailey M.

    Normal-flow virus filtration: detection and assessment of the endpoint in bio-processing. Biotechnol. Appl. Biochem. 2005, 42(2), 133–142.

    OpenUrlPubMed
43. 43.↵
    1. Slocum A.,
    2. Burnham M.,
    3. Genest P.,
    4. Venkiteshwaran A.,
    5. Chen D.,
    6. Hughes J.

    Impact of virus preparation quality on parvovirus filter performance. Biotechnol Bioeng. 2013, 110(1), 229–239.

    OpenUrlPubMed
44. 44.↵
    1. Asher D.,
    2. Slocum A.,
    3. Bergmann K.,
    4. Genest P.,
    5. Katz A.,
    6. Morais J.,
    7. Lawrence C.,
    8. Greenhalgh P.

    Predicting virus filtration performance with virus spike characterization. BioProcess Int. 2011, 9(3), 26–37.

    OpenUrl
45. 45.↵
    1. Stuckey J.,
    2. Strauss D.,
    3. Venkiteshwaran A.,
    4. Gao J.,
    5. Luo W.,
    6. Quertinmont M.,
    7. O'Donnell S.,
    8. Chen D.

    A novel approach to achieving modular retrovirus clearance for a parvovirus filter. Biotechnol. Prog. 2014, 30(1), 79–85.

    OpenUrl
46. 46.↵
    1. Blumel J.

    , Paul Ehrlich Institut, Germany. Reduced Viral Clearance Program Based on Platform Data for Biotech and Plasma Derived Products. PDA European Virus & TSE Safety Forum, Barcelona, Spain, 2011.
47. 47.↵
    1. King K.

    FDA CDER. Virus Clearance Integration: Critical Considerations and Orthogonality. PDA European Virus & TSE Safety Forum, Berlin, Germany, 2013.