Use of MMV as a single worst-case model virus in viral filter validation studies

PDA Journal of Pharmaceutical Science and Technology

Volumn 68, Issue 3, 2014, Pages 297-311

  Gefroh, Eva ^a   Dehghani, Houman ^a   McClure, Megan ^a   Connell Crowley, Lisa ^a   Vedantham, Ganesh ^a  

^a AMGEN INC   (United States)

Author keywords

MMV only; Parvovirus; Viral clearance; Viral filtration

Indexed keywords

ARTICLE; MEMBRANE FILTER; NONHUMAN; PARVOVIRUS; PROCESS MODEL; RISK ASSESSMENT; VALIDATION STUDY; VIRAL CLEARANCE; DEVICES; DRUG CONTAMINATION; EQUIPMENT DESIGN; FILTRATION; ISOLATION AND PURIFICATION; MICROPORE FILTER; MINUTE VIRUS OF MICE; PARTICLE SIZE; PATIENT SAFETY; PHARMACEUTICS; PREVENTION AND CONTROL; PRODUCT SAFETY; VIRION; VIROLOGY;

DRUG;

BIOPHARMACEUTICS; CONSUMER PRODUCT SAFETY; DRUG CONTAMINATION; EQUIPMENT DESIGN; FILTRATION; MICROPORE FILTERS; MINUTE VIRUS OF MICE; PARTICLE SIZE; PATIENT SAFETY; PHARMACEUTICAL PREPARATIONS; VIRION; VIROLOGY;

EID: 84903599876     PISSN: 10797440     EISSN: 19482124     Source Type: Journal    
DOI: 10.5731/pdajpst.2014.00978     Document Type: Article

References (47)

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. 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. 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. Zhou, J. X.; Solamo, F.; Hong, T.; Shearer, M.; Tressel, T. Viral clearance using disposable systems in monoclonal antibody commercial downstream processing. Biotechnol. Bioeng. 2008, 100(3), 488-496. (Pubitemid 351792925)
5. Kundu, A.; 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. Carter, J.; Lutz, H. An overview of viral filtration in biopharmaceutical manufacturing. Eur. J. Parenter. Sci. 2002, 7(3), 72-78.
7. Levy, R. V.; Phillips, M. W.; 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. Miesegaes, G.; Lute, S.; Aranha, H.; Brorson, K.; Flickinger, M. C. Virus Retentive Filters. In Encyclopedia of Industrial Biotechnology, Flickinger, M. C., Ed.; John Wiley & Sons, Inc.: New York, 2009.
9. Miesegaes, G.; Lute, S.; Dement-Brown, J.; Kaushal, S.; Strauss, D.; Chen, D.; 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.
10. Garnick, R. L. Experience with viral contamination in cell culture. Dev. Biol. Stand. 1996, 88, 49-56.
11. Miesegaes, G.; Bailey, M.; Willkommen, H.; Chen, Q.; Roush, D.; Blumel, J.; Brorson, K. Proceedings of the 2009 Viral Clearance Symposium. Dev Biol (Basel) 2010, 133, 3-101.
12. PDA Technical Report No. 41: Virus Filtration. Parenteral Drug Association: Bethesda, MD, 2008.
13. Brorson, K.; Krejci, S.; Lee, K.; Hamilton, E.; Stein, K.; 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. (Pubitemid 36402545)
14. Curtis, S.; Lee, K.; Blank, G. S.; Brorson, K.; Xu, Y. Generic/matrix evaluation of SV40 clearance by anion exchange chromatography in flow-through mode. Biotechnol. Bioeng. 2003, 84(2), 179-186. (Pubitemid 37176329)
15. Willkommen, H.; Blümel, J.; Brorson, K.; Chen, D.; Chen, Q.; Gröner, A.; Kreil, T. R.; Robertson, J. S.; Ruffing, M.; Ruiz, S. Meeting Report: PDA Virus and TSE Safety Forum. PDA J. Pharm. Sci. Technol. 2013, 67(2), 81-97.
16. Willkommen, H.; Blümel, J.; Brorson, K.; Chen, D.; Chen, Q.; Gröner, A.; Kreil, T. R.; Robertson, J. S.; Ruffing, M.; Ruiz, S. Meeting report - workshop on virus removal by filtration: trends and new developments. PDA J. Pharm. Sci. Technol. 2013, 67(2), 98-104.
17. Bakhshayeshi, M.; Jackson, N.; Kuriyel, R.; Mehta, A.; van Reis, R.; 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.
18. Phillips, M. W.; DiLeo, A. J. A validatible porosimetric technique for verifying the integrity of virus-retentive membranes. Biologicals 1996, 24(3), 243-253. (Pubitemid 27023388)
19. Peinador, R. I.; Calvo, J. I.; ToVinh, K.; Thom, V.; Prádanos, P.; Hernández, A. Liquid-liquid displacement porosimetry for the characterization of virus retentive membranes. J. Membr. Sci. 2011, 372(1-2), 366-372.
20. Bolton, G.; Cormier, J.; Krishnan, M.; Lewnard, J.; Lutz, H. Integrity testing of normal flow parvovirus filters using air-liquid based tests. Bioprocessing J. 2006, 5(1), 50.
21. Giglia, S.; Krishnan, M. High sensitivity binary gas integrity test for membrane filters. J. Membr. Sci. 2008, 323(1), 60-66.
22. Hirasaki, T.; Noda, T.; Nakano, H.; Ishizaki, Y.; Manabe, S.; 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.
23. Bakhshayeshi, M.; Kanani, D. M.; Mehta, A.; van Reis, R.; Kuriyel, R.; Jackson, N.; Zydney, A. L. Dextran sieving test for characterization of virus filtration membranes. J. Membr. Sci. 2011, 379(1), 239-248.
24. Lute, S.; Riordan, W.; Pease III, L. F. Tsai, D.-H.; Levy, R.; Haque, M.; Martin, J.; Moroe, I.; Sato, T.; Morgan, M.; Krishnan, M.; Campbell, J.; Genest, P.; Dolan, S.; Tarrach, K.; 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.
25. Grant, D. C.; Liu, B. Y. H. Sieving capture of liquidborne particles by microporous membrane filtration media. Particle & Particle Systems Characterization 1991, 8(1-4), 142-150.
26. DiLeo, A. J.; Vacante, D. A.; 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. (Pubitemid 24007533)
27. Grant, D. C.; Liu, B. Y. H.; Fisher, W. G.; 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.
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. ASTM F838 - 05 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, 2005.
30. Wurm, F. M. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat. Biotechnol. 2004, 22(11), 1393-1398. (Pubitemid 39482858)
31. Berting, A.; Farcet, M. R.; 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.
32. Garnick, R. L. Raw materials as a source of contamination in large-scale cell culture. Dev. Biol. Stand. 1998, 93, 21-29.
33. Nims, R. W. Detection of adventitious viruses in biologicals - a rare occurrence. Dev. Biol. (Basel) 2006, 123, 153-64, discussion 183-197.
34. Oehmig, A.; Buttner, M.; Weiland, F.; Werz, W.; Bergemann, K.; Pfaff, E. Identification of a calicivirus isolate of unknown origin. J. Gen. Virol. 2003, 84(10), 2837-2845. (Pubitemid 37220262)
35. Onions, D. Animal virus contaminants of biotechnology products. Dev. Biol. (Basel) 2004, 118, 155-163.
36. Moody, M.; Alves, W.; Varghese, J.; 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.
37. Victoria, J. G.; Wang, C.; Jones, M. S.; Jaing, C.; McLoughlin, K.; Gardner, S.; 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.
38. nd ed.; Springer: New York, 2011.
39. PDA Technical Report No. 47: Preparation of Virus Spikes Used for Virus Clearance Studies. Parenteral Drug Association: Bethesda, MD, 2010.
40. Cabatingan, M. Impact of virus stock quality on virus filter validation. BioProcess Int. 2005, 3(10), S39-S43.
41. Khan, N. Z.; Parrella, J. J.; Genest, P. W.; 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.
42. Bolton, G.; Cabatingan, M.; Rubino, M.; Lute, S.; Brorson, K.; Bailey, M. Normal-flow virus filtration: detection and assessment of the endpoint in bio-processing. Biotechnol. Appl. Biochem. 2005, 42(2), 133-142. (Pubitemid 41445234)
43. Slocum, A.; Burnham, M.; Genest, P.; Venkiteshwaran, A.; Chen, D.; Hughes, J. Impact of virus preparation quality on parvovirus filter performance. Biotechnol Bioeng. 2013, 110(1), 229-239.
44. Asher, D.; Slocum, A.; Bergmann, K.; Genest, P.; Katz, A.; Morais, J.; Lawrence, C.; Greenhalgh, P. Predicting virus filtration performance with virus spike characterization. BioProcess Int. 2011, 9(3), 26-37.
45. Stuckey, J.; Strauss, D.; Venkiteshwaran, A.; Gao, J.; Luo, W.; Quertinmont, M.; O'Donnell, S.; Chen, D. A novel approach to achieving modular retrovirus clearance for a parvovirus filter. Biotechnol. Prog. 2014, 30(1), 79-85.
46. 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. King, K. FDA CDER. Virus Clearance Integration: Critical Considerations and Orthogonality. PDA European Virus & TSE Safety Forum, Berlin, Germany, 2013.