Meeting Report: 2013 PDA Virus & TSE Safety Forum

References

1. 1.↵
   1. Baylis S. A.,
   2. Koc Ö.,
   3. Nick S.,
   4. Blümel J.

   Widespread distribution of hepatitis E virus in plasma fractionation pools. Vox Sang. 2012, 102 (2), 182–183.

   OpenUrlCrossRefPubMed
2. 2.↵
   1. Alter H.

   HEV prevalence and risk in U.S. blood donors and recipients: Current study and proposed study designs. 10th meeting of the Blood Products Advisory Committee, 20 Sept. 2012, http://www.fda.gov
3. 3.↵
   1. Burbelo P. D.,
   2. Dubovi E. J.,
   3. Simmonds P.,
   4. Medina J. L.,
   5. Henriquez J. A.,
   6. Mishra N.,
   7. Wagner J.,
   8. Tokarz R.,
   9. Cullen J. M.,
   10. Iadarola M. J.,
   11. Rice C. M.,
   12. Lipkin W. I.,
   13. Kapoord A.

   Serology-enabled discovery of genetically diverse hepaciviruses in a new host. J. Virol. 2012, 86 (11), 6171–6178.

   OpenUrlAbstract/FREE Full Text
4. 4.↵
   1. Rubino M. J.

   Experience with HEK293: a human cell line. PDA J. Pharm. Sci. Technol. 2010, 64 (5), 392–395.

   OpenUrlAbstract/FREE Full Text
5. 5.↵
   ICH Q5A (R1): Note for Guidance on Quality of Biotechnological Products: Viral Safety of Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5A_R1/Step4/Q5A_R1__Guideline.pdf
6. 6.↵
   EMA/CHMP/BWP/310732/2012: Work plan for the CHMP Biologics Working Party (BWP), 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2009/10/WC500004664.pdf
7. 7.↵
   EMA/CHMP/BWP/457920/2012 rev 1: Guideline on the use of bovine serum in the manufacture of human biological medicinal product. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500143930.pdf
8. 8.↵
   EMA/CHMP/267815/2011: Assessment report for Art 5(3) procedure: Detection by a highly sensitive new PCR technique of genomic fragments from enodenous and adventitious viral agents in live attenuated vaccines. November 18, 2011 www.ema.europa.eu/docs/en_GB/document_library/Report/2012/02/WC500122741.pdf
9. 9.↵
   EMA/CHMP/BWP/814397/2011, Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products, Draft. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139532.pdf
10. 10.↵
    1. Marcus-Secura C.,
    2. Richardson J. C.,
    3. Harston R. K.,
    4. Sane N.,
    5. Sheets R. L.

    Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products. Biologicals 2011, 39 (6), 359–369.

    OpenUrlPubMed
11. 11.↵
    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
12. 12.↵
    1. Kapusinszky B.,
    2. Minor P.,
    3. Delwart E.

    Nearly constant shedding of diverse enteric viruses by two healthy infants. J. Clin. Microbiol. 2012, 50 (11), 3427–3434.

    OpenUrlAbstract/FREE Full Text
13. 13.↵
    1. Li L.,
    2. Kapoor A.,
    3. Slikas B.,
    4. Bamidele O. S.,
    5. Wang C.,
    6. Shaukat S.,
    7. Masroor M. A.,
    8. Wilson M. L.,
    9. Ndjango J. B.,
    10. Peeters M.,
    11. Gross-Camp N. D.,
    12. Muller M. N.,
    13. Hahn B. H.,
    14. Wolfe N. D.,
    15. Triki H.,
    16. Bartkus J.,
    17. Zaidi S. Z.,
    18. Delwart E.

    Multiple diverse circoviruses infect farm animals and are commonly found in human and chimpanzee feces. J. Virol. 2010, 84 (4), 1674–1682.

    OpenUrlAbstract/FREE Full Text
14. 14.↵
    1. Shan T.,
    2. Li L.,
    3. Simmonds P.,
    4. Wang C.,
    5. Moeser A.,
    6. Delwart E.

    The fecal virome of pigs on a high-density farm. J. Virol. 2011, 85 (22), 11697–11708.

    OpenUrlAbstract/FREE Full Text
15. 15.↵
    1. Jones M. S.,
    2. Kapoor A.,
    3. Lukashov V. V.,
    4. Simmonds P.,
    5. Hecht F.,
    6. Delwart E.

    New DNA viruses identified in patients with acute viral infection syndrome. J. Virol. 2005, 79 (13), 8230–8236.

    OpenUrlAbstract/FREE Full Text
16. 16.↵
    1. Gard G.,
    2. Fair J. N.,
    3. Lee D.,
    4. Slikas E.,
    5. Steffen I.,
    6. Muyembe J. J.,
    7. Sittler T.,
    8. Veeraraghavan N.,
    9. Ruby J. G.,
    10. Wang C.,
    11. Makuwa M.,
    12. Mulembakani P.,
    13. Tesh R. B.,
    14. Mazet J.,
    15. Rimoin A. W.,
    16. Taylor T.,
    17. Schneider B. S.,
    18. Simmons G.,
    19. Delwart E.,
    20. Wolfe N. D.,
    21. Chiu C. Y.,
    22. Leroy E. M.

    A novel rhabdovirus associated with acute hemorrhagic fever in central Africa. PLoS Pathog. 2012, 8 (9), e1002924. doi: 10.1371/journal.ppat.1002924.

    OpenUrlCrossRefPubMed
17. 17.↵
    1. Baylis S. A.,
    2. Tuke P. W.,
    3. Miyagawa E.,
    4. Blümel J.

    Studies on the inactivation of human parvovirus 4. Transfusion 2013, 53 (10 pt 2), 2585–2592.

    OpenUrl
18. 18.↵
    1. Steinmann J.,
    2. Becker B.,
    3. Bischoff B.,
    4. Paulmann D.,
    5. Friesland M.,
    6. Pietschmann T.,
    7. Steinmann J.,
    8. Steinmann E.

    Virucidal activity of 2 alcohol-based formulations proposed as hand rubs by the World Health Organization. Am. J. Infect. Control 2010, 38 (1), 66–68.

    OpenUrlCrossRefPubMed
19. 19.↵
    1. Doerrbecker J.,
    2. Friesland M.,
    3. Ciesek S.,
    4. Erichsen T. J.,
    5. Mateu-Gelabert P.,
    6. Steinmann J.,
    7. Steinmann J.,
    8. Pietschmann T.,
    9. Steinmann E.

    Inactivation and survival of hepatitis C virus on inanimate surfaces. J. Infect. Dis. 2011, 204 (12), 1830–1838.

    OpenUrlAbstract/FREE Full Text
20. 20.↵
    1. Doerrbecker J.,
    2. Meuleman P.,
    3. Kang J.,
    4. Riebesehl N.,
    5. Wilhelm C.,
    6. Friesland M.,
    7. Pfaender S.,
    8. Steinmann J.,
    9. Pietschmann T.,
    10. Steinmann E.

    Thermostability of seven hepatitis C virus genotypes in vitro and in vivo. J. Viral. Hepat. 2013, 20 (7), 478–485.

    OpenUrlCrossRefPubMed
21. 21.↵
    1. Behrendt P.,
    2. Doerrbecker J.,
    3. Riebesehl N.,
    4. Wilhelm C.,
    5. Ciesek S.,
    6. Erichsen T. J.,
    7. Steinmann J.,
    8. Ott M.,
    9. Manns M. P.,
    10. Pietschmann T.,
    11. Steinmann E.

    Stability and transmission of hepatitis C virus in different anesthetic agents. Am. J. Infect. Control. 2013, 41 (10), 942–943.

    OpenUrlPubMed
22. 22.↵
    1. Steinmann E.,
    2. Gravemann U.,
    3. Friesland M.,
    4. Doerrbecker J.,
    5. Müller T. H.,
    6. Pietschmann T.,
    7. Seltsam A.

    Two pathogen reduction technologies—methylene blue plus light and shortwave ultraviolet light—effectively inactivate hepatitis C virus in blood products. Transfusion 2013, 53 (5), 1010–1018.

    OpenUrlCrossRef
23. 23.↵
    European Pharmacopoeia. Draft Monograph Human Plasma (Pooled and Treated for Virus Inactivation (1646). Reference: PA/PH/Exp. 6B/T (12) 13 ANP.
24. 24.↵
    1. Yunoki M.,
    2. Yamamoto S.,
    3. Tanaka H.,
    4. Nishigaki H.,
    5. Tanaka Y.,
    6. Nishida A.,
    7. Ikuta K.

    Extent of hepatitis E virus elimination is affected by stabilizers present in plasma products and pore size of nanofilters. Vox Sang. 2008, 95 (2), 94–100.

    OpenUrlCrossRefPubMed
25. 25.↵
    1. Nettleton P. F.,
    2. Rweyemanu M. M.

    The association of calf serum with the contamination of BHK21 clone 13 suspension cells by a parvovirus serologically related to the minute virus of mice (MVM). Arch. Virol. 1980, 64 (4), 359–374.

    OpenUrlPubMed
26. 26.↵
    1. Zoletto R.

    Parvovirus serologically related to the minute virus of mice (MVM) as contaminant of BHK 21 cl. 13 suspension cells. Dev. Biol. Stand. 1985, 60, 179–183.

    OpenUrlPubMedWeb of Science
27. 27.↵
    1. Garnick R. L.

    Experience with viral contamination in cell culture. Dev. Biol. Stand. 2006, 88, 49–56.

    OpenUrl
28. 28.↵
    1. Skrine J.

    A biotech production facility contamination case study—minute mouse virus. PDA J. Pharm. Sci. Technol. 2011, 65 (6), 599–611.

    OpenUrlAbstract/FREE Full Text
29. 29.↵
    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
30. 30.↵
    1. Spier R. E.

    1. Wiebe M. E.,
    2. Becker F.,
    3. Lazar R.,
    4. May L.,
    5. Casto B.,
    6. Semense M.,
    7. Fautz C.,
    8. Garnick R.,
    9. Miller C.,
    10. Masover G.,
    11. Bergmann D.,
    12. 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., Ed.; Butterworths: London, 1989; pp 68–71.
31. 31.↵
    1. Poiley J. A.,
    2. Nelson R. E.,
    3. Hillesund T.,
    4. Raineri R.

    Susceptibility of CHO-K1 cells to infection by eight adventitious viruses and four retroviruses. In Vitro Toxicol. 1991, 4 (1), 1–12.

    OpenUrl
32. 32.↵
    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.

    OpenUrlCrossRefPubMed
33. 33.↵
    1. Marcus-Sekura C.,
    2. Richardson J. C.,
    3. Harston R. K.,
    4. Sane N.,
    5. Sheets R. L.

    Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products. Biologicals 2011, 39 (6), 359–369.

    OpenUrlPubMed
34. 34.↵
    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.

    OpenUrlCrossRefPubMed
35. 35.↵
    http://www.niaid.nih.gov/topics/hivaids/research/vaccines/resources/reagent/pages/default.aspx(accessed July 10, 2013).
36. 36.↵
    1. Cheval J.,
    2. Sauvage V.,
    3. Frangeul L.,
    4. Dacheux L.,
    5. Guigon G.,
    6. Dumey N.,
    7. Pariente K.,
    8. Rousseaux C.,
    9. Dorange F.,
    10. Berthet N.,
    11. Brisse S.,
    12. Moszer I.,
    13. Bourhy H.,
    14. Manuguerra C. J.,
    15. Lecuit M.,
    16. Burguiere A.,
    17. Caro V.,
    18. Eloit M.

    ; Evaluation of high-throughput sequencing for identifying known and unknown viruses in biological samples. J. Clin. Microbiol. 2011, 49 (9), 3268–3275.

    OpenUrlAbstract/FREE Full Text
37. 37.↵
    1. Sauvage V.,
    2. Cheval J.,
    3. Foulongne V.,
    4. Gouilh M. A.,
    5. Pariente K.,
    6. Manuguerra J. C.,
    7. Richardson J.,
    8. Dereure O.,
    9. Lecuit M.,
    10. Burguiere A.,
    11. Caro V.,
    12. Eloit M.

    Identification of the first human gyrovirus, a virus related to chicken anemia virus. J. Virol. 2011, 85 (15), 7948–7950.

    OpenUrlAbstract/FREE Full Text
38. 38.↵
    1. Sauvage V.,
    2. Ar Gouilh M.,
    3. Cheval J.,
    4. Muth E.,
    5. Pariente K.,
    6. Burguiere A.,
    7. Caro V.,
    8. Manuguerra J. C.,
    9. Eloit M.

    A member of a new Picornaviridae genus is shed in pig feces. J. Virol. 2012, 86 (18), 10036–10046.

    OpenUrlAbstract/FREE Full Text
39. 39.↵
    Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use, CBER/FDA, 1997.
40. 40.↵
    1. Mieseges,
    2. Bailey M,
    3. Willkommen H,
    4. Chen Q,
    5. Roush D,
    6. Blümel J,
    7. Brorson K.

    Proceedings of the 2009 Viral Clearance Symposium. Developments in Biologicals 2009, 133, 2011.

    OpenUrl
41. 41.↵
    ASTM Standard WK36552. Protocol for Evaluation of Virus Inactivation using Low pH Treatment.
42. 42.↵
    1. Grassman A.,
    2. Wolf H.,
    3. Hofmann J.,
    4. Graham J.,
    5. Vorberg I.

    Cellular aspects of prion replication in vitro. Viruses 2013, 5 (1), 374–405.

    OpenUrlCrossRefPubMed
43. 43.↵
    1. Piccardo P.,
    2. Cervenakova L.,
    3. Vasilyeva I.,
    4. Yakovleva O.,
    5. Bacik I.,
    6. Cervenak J.,
    7. McKenzie C.,
    8. Kurillova L.,
    9. Gregori L.,
    10. Pomeroy K.,
    11. Asher D. M.

    Candidate cell substrates, vaccine production, and transmissible spongiform encephalopathies. Emerg. Infect. Dis. 2011, 17 (12), 2262–2269.

    OpenUrlCrossRefPubMed