Evolution of approaches to viral safety issues for biological products

PDA Journal of Pharmaceutical Science and Technology

Volumn 65, Issue 6, 2011, Pages 547-556

  Lubiniecki, Anthony S ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Adventitious viral agents; Biological products; In vitro virus screening; In vivo virus screening; PCR testing; Viral clearance; Viral inactivation; Viral safety

Indexed keywords

ALBUMIN; BIOLOGICAL PRODUCT; BLOOD CLOTTING FACTOR 8; IMMUNOGLOBULIN; RECOMBINANT DNA; VIRUS VACCINE; VIRUS DNA;

BIOTECHNOLOGY; CELL CULTURE; CONFERENCE PAPER; DRUG BIOAVAILABILITY; HUMAN; IN VITRO STUDY; IN VIVO STUDY; NONHUMAN; VIRAL CLEARANCE; VIRAL CONTAMINATION; VIRUS DETECTION; VIRUS INFECTION; VIRUS LOAD; DRUG CONTAMINATION; HUMAN IMMUNODEFICIENCY VIRUS 1; ISOLATION AND PURIFICATION; PREVENTION AND CONTROL; VIRUS;

BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; DNA, VIRAL; DRUG CONTAMINATION; HIV-1; HUMANS; VIRAL VACCINES; VIRUS DISEASES; VIRUSES;

EID: 84855552229     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: 10.5731/pdajpst.2011.00818     Document Type: Conference Paper

References (44)

1. Enders, J. F.; Weller, T. H.; Robbins, F. C. Cultivation of the Lansing strain of poliomyelitis virus in culture. Science 1949, 109, 85-87.
2. Kalter, S. S.; Ablashi, D.; Espana, C.; Heberling, R. L.; Hull, R. N.; Lennette, E. H.; Malherbe, H. H.; McConnell, S.; Yohn, D. S. Simian virus nomenclature, 1980. Intervirology 1980, 13 (6), 317-330.
3. Shah, K.; Nathanson, N. Human exposure to SV40; Review and comment. Am. J. Epidemiol. 1976, 103, 1-12.
4. Waters, T. D.; Anderson, P. S.; Beebe, G. W.; Miller, R. W. Yellow fever vaccination, avian leukosis virus, and cancer risk in man. Science 1972, 177, 76-77.
5. Petricciani, J. C.; Chu, F. C.; Johnson, J. B. Bacteriophages in live virus vaccines. Proc. Soc. Exp. Biol. Med. 1973, 144, 789-791.
6. Huff, J. L.; Barry, P. A. B-virus (Cercopithecine herpesvirus 1) infection in humans and macaques: potential for zoonotic disease. Emerg. Infect. Dis. 2003, 9 (2), 246-250. (Pubitemid 36231798)
7. Martini, G. A. Marburg agent disease: in man. Royal Soc. Trop. Med. Hyg. 1969, 63 (3), 295-301.
8. Nathanson, N.; Langmuir, A. D. The Cutter incident: poliomyelitis following formaldehyde-inactivated poliovirus vaccination in the United States during the spring of 1955. II. Relationship of poliomyelitis to Cutter vaccine. Am. J. Hyg. 1963, 78, 29-60.
9. Para, M. An outbreak of post-vaccinal rabies (rage de laboratoire) in Fortazela, Brazil in 1960. Bull. World Health. Org. 1965, 33 (2), 177-182.
10. Cann, A. J.; Stanway, G.; Hughes, P. J.; Minor, P. D.; Evans, D. M. A.; Schild, G. C.; Almond, J. W. Reversion to neurovirulence of the live-attenuated sabin type 3 oral poliovirus vaccine. Nucleic Acids Res. 1984, 12 (20), 7787-7792.
11. Brown, E. G.; Furesz, J.; Dimock, K.; Yarosh, W.; Contreras, G. Nucleotide sequence analysis of Urabe mumps vaccine strain that caused meningitis in vaccine recipients. Vaccine 1991, 9 (11), 840-842.
12. Edelman, R.; Ascher, M. S.; Oster, C. N.; Ramsburg, H. H.; Cole, F. E.; Eddy, G. A. Evaluation in humans of a new, inactivated vaccine for Venezuelan equine encephalitis virus (C-84). J. Infect. Dis. 1979, 140 (5), 708-715.
13. Bancroft, W. H.; Scott, R. M.; Eckels, K. H.; Hoke, C. H.; Simms, T. E.; Jesrani, K. D. T.; Summers, P. L.; Dubois, D. R.; Tsoulos, D.; Russell, P. K. Dengue virus type 2 vaccine: reactogenicity and immunogenicity in soldiers. J. Infect. Dis. 1984, 149 (6), 1005-1010.
14. Steinhauer, D. A.; Domingo, E.; Holland, J. J. Lack of evidence for proofreading mechanisms associated with an RNA virus polymerase. Gene 1992, 122 (2), 281-288. (Pubitemid 23030332)
15. Hacein-Bey-Abina, S.; von Kalle, C.; Schmidt, M.; Le Deist, F.; Wulffraat, N.; Mclntyre, l.; Radford, E.; Villeval, J. L.; Fraser, C. C.; Cavazzana-Calvo, M.; Fischer, A. A serious adverse event after successful gene therapy for X-linked severe combinedimmunodeficiency. N. Engl. J. Med. 2003, 348, 255-256.
16. Wilson, G. The Hazards of Immunization; Anthlone Press, University of London: London, 1967.
17. Sawyer, W. A.; Meyer, K. F.; Eaton, M. D.; Bauer, J. H.; Putnam, P.; Schwentker, F. F. Jaundice in Army personnel in the western region of the United States and its relation to vaccination against yellow fever. Amer. J. Hyg. 1944, 39, 337-430.
18. Morgenthaler, J. J.; Omar, A. Partitioning and inactivation of viruses during isolation of albumin and immunoglobulins by cold ethanol fractionation. Dev. Biol. Stand. 1993, 81, 185-190.
19. Dodd, R. Y. Hepatitis C, other types of non-B parenteral hepatitis and blood transfusion. Dev. Biol. Stand. 1993, 81, 35-40.
20. Yu, M. W. Follow-up studies of hepatitis C association with an intravenous immunoglobulin. Dev. Biol. Stand. 1996, 81, 215-216.
21. Barrowcliffe, T. W. Viral inactivation vs biological activity. Dev. Biol. Stand. 1993, 81, 125-135.
22. Garson, J. A.; Tedder, R. S.; Briggs, M.; Tuke, P.; Glazebrook, J. A.; Trute, A.; Parker, D.; Barbara, J. A.; Contreras, M.; Aloysius, S. Detection of hepatitis C viral sequences in blood donations by "nested" polymerase chain reaction and prediction of infectivity. Lancet 1990, 335 (8703), 1419-1422. (Pubitemid 20186435)
23. Saldanha, J.; Minor, P. D. Detection of human parvovirus B19 DNA in plasma pools and blood products derived from these pools: implications for efficacy and consistency of removal of B19 DNA during manufacture. Brit. J. Haematol. 1996, 93, 714-719.
24. Fox, J. L. French court rules on HIV-contaminated blood lawsuit. Am. Soc. Microbiol. News 1999, 65, 397.
25. Nathan, R. Guilty pleas intensify row over contaminated blood. Nature Medicine 1997, 3, 480-481. (Pubitemid 27198632)
26. Nash, D.; Mostashi, F.; Fine, A. The outbreak of West Nile virus infection in the New York City area in 1999. N. Engl. J. Med. 2001, 344, 1807-1814. (Pubitemid 32538693)
27. Owen, J.; Moore, F.; Panella, N. Migrating birds as dispersal vehicles for West Nile virus. EcoHealth 2006, 3, 1-7.
28. Pealer, L. N.; Marfin, A. A.; Petersen, L. R. Transmission of West Nile virus through blood transfusion in the United States in 2002. N. Engl. J. Med. 2003, 349, 1236-1245. (Pubitemid 37152033)
29. Lubiniecki, A. S.; May, L. H. Cell bank characterization for recombinant DNA mammalian cell lines. Dev. Biol. Stand. 1985, 60, 141-146.
30. Petricciani, J. C. Regulatory considerations for products derived from the new biotechnology. Pharm. Manufact. 1985, 5, 31-34.
31. Lubiniecki, A. S. Safety Considerations for Cell Culture-Derived Biologicals. In Large Scale Cell Culture; Lydersen, B. K., Ed.; Carl Hanser: Munich, 1987; 231-247.
32. Wiebe, M. E. Becker, F.; Lazar, R.; May, L. Casto, B.; Semense, C.; Fautz, C.; Garnick, R.; Miller, C.; Massover, G.; Bergmann, D.; Lubiniecki, A. S. A Multifaceted Approach To Assure That Recombinant tPA Is Free of Adventitious Virus. In Advances in Animal Cell Biology and Technology for Bioprocesses; Spier, R. E., Griffiths, J. B., Stephenne, J., Crooy, P. J., Eds.; Butterworths: London, 1989; pp 68-72.
33. Mortimer, P. P.; Luban, N. L. C.; Kelleher, J. F.; Cohen, B. J. Transmission of serum parvovirus-like virus by clotting-factor concentrates. Lancet 1983, 2 (8348), 482-484. (Pubitemid 13040001)
34. Mannucci, P. M. Outbreak of hepatitis A among Italian patients with hemophilia. Lancet 1992, 339 (8796), 819.
35. Garnick, R. L. Experience with viral contaminaton in cell culture. Dev. Biol. Stand. 1996, 88, 49-56.
36. Letters to biological manufacturers, FDA, May 3, 1991 and December 17, 1993.
37. Lubiniecki, A.; Arathoon, R.; Polastri, G.; Thomas, J.; Wiebe, M.; Garnick, R.; Jones, A.; van Reis, R.; Builder, S. Selected Strategies for Manufacture and Control of Recombinant Tissue Plasminogen Activator Prepared from Cell Cultures. In Advances in Animal Cell Biology and Technology for Bioprocesses; Spier, R. E., Griffiths, J. B., Stephenne, J., Crooy, P. J., Eds.; Butterworths: London, 1989; pp 442-451.
38. Rabenau, H.; Ohlinger, V.; Anderson, J.; Selb, B.; Cinatl, J.; Wolf, W.; Frost, J.; Mellor, P.; Doerr, H. W. Contamination of genetically engineered CHO-cells by epizootic haemorrhagic disease virus (EHDV). Biologicals 1993, 21 (3), 207-214. (Pubitemid 24007525)
39. Nims, R. W.; Dusing, S. K.; Hsieh, W. T.; Lovatt, A.; Reid, G. G.; Onions, D.; Milne, E. W. Detection of Cache Valley virus in biologics manufactured in CHO cells. Biopharm. Intl. 2008, 21 (10), 89-94.
40. Oehmig, A.; Buttner, M.; Weiland, F.; Werz, W.; Bergmann, K.; Pfaff, E. Identification of a calicivirus isolate of unknown origin. J. Gen. Virol. 2003, 84, 2837-2844.
41. Hughes, P. F. FDA perspective on mycoplasma contaminations in manufacturing dues to use of peptones. In Proceedings from the PDA Workshop on Mycoplasma Contamination by Plant Peptones; Potts, B. J., Ed.; PDA: Rockville, MD, 2007; pp 73-92.
42. Victoria, G. J.; 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.
43. Kiss, R. Practicing safe cell culture: applied process designs for minimizing virus contamination risk. PDA J. Pharm. Sci. Technol. 2011, 65 (6).
44. Mercaldi, M. Examining the effect of UV-C Irradiation on the biochemical properties of an IgG. In Kiss, R.; Drews, R. Breakout Session A Summary. 2010 PDA-FDA meeting. DOI 10.5731/pdajpst.2011.00850.