Meeting Report: PDA Virus and TSE Safety Forum

References

1. 1.↵
   ICH Q5A (R1): Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. CPMP/ICH/295/95. October 1997. http://www.ema.europa.eu.
2. 2.↵
   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
3. 3.↵
   EMA/CHMP/BWP/548524/2008: Guideline on epidemiological data on blood transmissible infection. 22 April 2010. http://www.ema.europa.eu.
4. 4.↵
   1. Murphy M.,
   2. Quesada G. M.,
   3. Chen D.

   Effectiveness of mouse minute virus inactivation by high temperature short time treatment technology: a statistical assessment. Biologicals 2011, 39 (6): 438–443.

   OpenUrlPubMed
5. 5.↵
   1. Onions D.,
   2. Kolman J.

   Massively parallel sequencing, a new method for detecting adventitious agents. Biologicals 2010, 38 (3), 377–380.

   OpenUrlPubMed
6. 6.↵
   1. Sampath R.,
   2. Blyn L. B.,
   3. Ecker D. J.

   Rapid molecular assays for microbial contaminant monitoring in the bioprocess industry. PDA J. Pharm. Sci. Technol. 2010, 64 (5), 458–464.

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. C. R. Ill.,
   2. Dehghani H.

   Risk reduction in biotherapeutic products. Curr. Opin. Drug Discov. Devel. 2009, 12 (2), 296–304.

   OpenUrlPubMed
8. 8.↵
   1. Lawrence B.,
   2. Bashiri H.,
   3. Dehghani H.

   Cross comparison of rapid mycoplasma detection platforms. Biologicals 2010, 38 (2), 218–223.

   OpenUrlPubMed
9. 9.↵
   1. Lamson D.,
   2. Renwick N.,
   3. Kapoor V.,
   4. Liu Z.,
   5. Palacios G.,
   6. Ju J.,
   7. Dean A.,
   8. St. George K.,
   9. Briese T.,
   10. Lipkin W. I.

   MassTag polymerase-chain-reaction detection of respiratory pathogens, including a new rhinovirus genotype, that caused influenza-like illness in New York State during 2004–2005. J. Infect. Dis. 2006, 194 (10), 1398–1402.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Palacios G.,
    2. Quan P.-L.,
    3. Jabado O. J.,
    4. Conlan S.,
    5. Hirschberg D. L.,
    6. Liu Y.,
    7. Zhai J.,
    8. Renwick N.,
    9. Hui J.,
    10. Hegyi H.,
    11. Grolla A.,
    12. Strong J. E.,
    13. Towner J. S.,
    14. Geisbert T. W.,
    15. Jarhling P. B.,
    16. Büchen-Osmond C. V.,
    17. Ellerbrok H.,
    18. Sanchez-Seco M. P.,
    19. Lussier Y.,
    20. Formenty P.,
    21. Nichol S. T.,
    22. Feldmann H.,
    23. Briese T.,
    24. Lipkin W. I.

    Panmicrobial oligonucleotide array for diagnosis of infectious diseases. Emerg. Infect. Dis. 2007, 13 (1), 73–81.

    OpenUrlCrossRefPubMedWeb of Science
11. 11.↵
    1. Briese T.,
    2. Paweska J. T.,
    3. McMullan L. K.,
    4. Hutchison S. K.,
    5. Street C.,
    6. Palacios G.,
    7. Khristova M. L.,
    8. Weyer J.,
    9. Swanepoel R.,
    10. Egholm M.,
    11. Nichol S. T.,
    12. Lipkin W. I.

    Genetic detection and characterization of Lujo virus, a new hemorrhagic fever-associated arenavirus from southern Africa. PLoS Pathog. 2009, 5 (5), e1000455.

    OpenUrlCrossRefPubMed
12. 12.↵
    1. Quan P. L.,
    2. Wagner T. A.,
    3. Briese T.,
    4. Torgerson T. R.,
    5. Hornig M.,
    6. Tashmukhamedova A.,
    7. Firth C.,
    8. Palacios G.,
    9. Baisre-de-Leon A.,
    10. Paddock C. D.,
    11. Hutchison S. K.,
    12. Egholm M.,
    13. Zaki S. R.,
    14. Goldman J. E.,
    15. Ochs H. D.,
    16. Lipkin W. I.

    Astrovirus encephalitis in boy with X-linked agammaglobulinemia. Emerg. Infect. Dis. 2010, 16 (6): 918–925.

    OpenUrlCrossRefPubMed
13. 13.↵
    1. Farcet M. R.,
    2. Kindermann J.,
    3. Modrof J.,
    4. Kreil T. R.

    Inactivation of hepatitis A variants during heat treatment (pasteurization) of human serum albumin. Transfusion 2012, 52 (1), 181–187.

    OpenUrl
14. 14.↵
    1. Miesegaes G.,
    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. Dev. Biol. 2011, 113, 3–104.

    OpenUrl
15. 15.↵
    1. Dichtelmuller H. O.,
    2. Biesert L.,
    3. Fabrizzi F.,
    4. Gajardo R.,
    5. Groner H.,
    6. Jorquera J. I.,
    7. Kempf C.,
    8. Kreil T. R.,
    9. Pifat W.,
    10. Osheroff W.,
    11. Poelsler G.

    Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies. Transfusion 2009, 49 (9), 1931–1943.

    OpenUrlCrossRef
16. 16.↵
    EMEA/CHMP/BWP/398498/2005: Guideline on virus safety evaluation of biotechnological investigational medicinal products. 1 February 2009. http://www.ema.europa.eu.
17. 17.↵
    OIE-World Organization of Animal Health: Bovine Spongiform Encephalopathy Status of Members according to Resolution No. 17, May 2011, http://www.oie.int/animal-health-in-the-world/official-disease-status/bse/list-of-bse-risk-status/.
18. 18.↵
    National Blood Service: Transfusion Medicine Epidemiologial Review (TMER). http://www.cjd.ed.ac.uk/TMER/TMER.htm.
19. 19.↵
    1. Peden A.,
    2. McCardle L.,
    3. Head M. W.,
    4. Love S.,
    5. Ward H. J. T.,
    6. Cousens S. N.,
    7. Keeling D. M.,
    8. Millar C. M.,
    9. Hill F. G. H.,
    10. Ironside J. W.

    Variant CJD infection in the spleen of a neurologically asymptomatic UK adult patient with haemophilia. Haemophilia 2010, 16 (2), 296–304.

    OpenUrlCrossRefPubMedWeb of Science
20. 20.↵
    1. Puopolo M.,
    2. Ladogana A.,
    3. Vetrugno V.,
    4. Pocchiari M.

    Transmission of sporadic Creutzfeldt-Jakob disease by blood transfusion: risk factor or possible biases. Transfusion 2011, 51 (7), 1556–1566.

    OpenUrlCrossRef
21. 21.↵
    European Commission: Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev. 3). OJ C73, 5.3.2011, pp 1–18.
22. 22.↵
    OIE: Terrestrial Animal Health Code, Chapter 11.5.: bovine spongiform encephalopathy. http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.11.5.htm.
23. 23.↵
    EMA/CHMP/BWP/303353/2010: CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products. 23 June 2011. http://www.ema.europa.eu.
24. 24.↵
    1. Hilton D. A.,
    2. Ghani A. C.,
    3. Conyers L.,
    4. Edwards P.,
    5. McCardle L.,
    6. Ritchie D.,
    7. Penney M.,
    8. Hegazy D.,
    9. Ironside J. W.

    Prevalence of lymphoreticular prion protein accumulation in UK tissue samples. J. Pathol. 2004, 203 (3), 733–739.

    OpenUrlCrossRefPubMedWeb of Science
25. 25.↵
    1. de Marco M. F.,
    2. Linehan J.,
    3. Gill O. N.,
    4. Clewley J. P.,
    5. Brandner S.

    Large-scale immunohistochemical examination for lymphoreticular prion protein in tonsil specimens collected in Britain. J. Pathol. 2010, 222 (4), 380–387.

    OpenUrlCrossRefPubMedWeb of Science
26. 26.↵
    1. Gregori L.,
    2. Kovacs G. G.,
    3. Alexeeva I.,
    4. Budka H.,
    5. Rohwer R. G.

    Excretion of transmissible spongiform encephalopathy infectivity in urine. Emerg. Infect. Dis. 2008, 14 (9), 1406–1412.

    OpenUrlCrossRefPubMed
27. 27.↵
    1. Edgeworth J. A.,
    2. Farmer M.,
    3. Sicilia A.,
    4. Tavares P.,
    5. Beck J.,
    6. Campbell T.,
    7. Lowe J.,
    8. Mead S.,
    9. Rudge P.,
    10. Collinge J.,
    11. Jackson G. S.

    Detection of prion infection in variant Creutzfeldt-Jakob disease: a blood based assay. Lancet 2011, 377 (9764), 487–493.

    OpenUrlCrossRefPubMedWeb of Science
28. 28.↵
    1. Wilham J. M.,
    2. Orrú C. D.,
    3. Bessen R. A.,
    4. Atarashi R.,
    5. Sano K.,
    6. Race B.,
    7. Meade-White K. D.,
    8. Taubner L. M.,
    9. Timmes A.,
    10. Caughey B.

    Rapid end-point quantitation of prion seeding activity with sensitivity comparable to bioassays. PLoS Pathog. 2010, 6 (12), e1001217, doi:10.1371/journal.ppat.1001217.

    OpenUrlCrossRefPubMed
29. 29.↵
    1. Pritzkow S.,
    2. Wagenführ K.,
    3. Daus M. L.,
    4. Boerner S.,
    5. Lemmer K.,
    6. Thomzig A.,
    7. Mielke M.,
    8. Beekes M.

    Quantitative detection and biological propagation of scrapie seeding activity in vitro facilitate use of prions as model pathogens for disinfection. PLoS One 2011, 6 (5), e20384, doi:10.1371/journal.pone.0020384.

    OpenUrlCrossRefPubMed
30. 30.↵
    1. Thyer J.,
    2. Unal A.,
    3. Hartel G.,
    4. Middleton D.,
    5. Bingham J.,
    6. Braun M.,
    7. Uren E.,
    8. Maher D.

    Investigation of prion removal/inactivation from chromatographic gel. Vox Sang. 2006, 91 (4), 301–308.

    OpenUrlPubMed
31. 31.↵
    CPMP/BWP/5136/03: Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regards to vCJD. 21 October 2004. http://www.ema.europa.eu.
32. 32.↵
    1. Yunoki M.,
    2. Tanaka H.,
    3. Urayama T.,
    4. Hattori S.,
    5. Ohtani M.,
    6. Ohkubo Y.,
    7. Kawabata Y.,
    8. Miyatake Y.,
    9. Nanjo A.,
    10. Iwao E.,
    11. Morita M.,
    12. Wilson E.,
    13. MacLean C.,
    14. Ikuta K.

    Prion removal by nanofiltration under different experimental conditions. Biologicals 2008, 36 (1), 27–36.

    OpenUrlPubMed
33. 33.↵
    1. Safar J. G.,
    2. Geschwind M. D.,
    3. Deering C.,
    4. Didorenko S.,
    5. Sattavat M.,
    6. Sanchez H.,
    7. Serban A.,
    8. Vey M.,
    9. Baron H.,
    10. Giles K.,
    11. Miller B. L.,
    12. DeArmond S. J.

    Diagnosis of human prion disease. Proc. Natl. Acad. Sci. 2005, 102 (9), 3501–3506.

    OpenUrlAbstract/FREE Full Text