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Research ArticleConference Report

Meeting Report—Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments

Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michael Ruffing, Sol Ruiz, Dorothy Scott and Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 215-220; DOI: https://doi.org/10.5731/pdajpst.2014.00981
Hannelore Willkommen
aRegulatory Affairs & Biological Safety Consulting, Erzhausen, Germany;
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  • For correspondence: hannelore.willkommen@gmx.de
Johannes Blümel
bPaul-Ehrlich-Institut, Langen, Germany;
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Kurt Brorson
cCDER/FDA, Silver Spring MD, USA;
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Dayue Chen
dGenentech Inc., South San Francisco, CA, USA;
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Qi Chen
eEli Lilly and Company, Indianapolis, IN, USA;
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Albrecht Gröner
fCSL Behring GmbH, Marburg, Germany;
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Brian R. Hubbard
gAmgen Inc., Thousand Oaks, CA, USA;
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Thomas R. Kreil
hBaxter BioScience, Vienna, Austria;
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Michael Ruffing
iBoehringer Ingelheim Pharma GmbH&KG, Bieberach an der Riss, Germany;
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Sol Ruiz
jSpanish Medicines Agency (AEMPS), Madrid, Spain;
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Dorothy Scott
kCBER/FDA, Silver Spring MD, USA;
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Glenda Silvester
lEuropean Medicines Agency, London, UK
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  • Article
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References

  1. 1.↵
    PDA Technical Report No. 41: Virus Filtration. PDA J. Pharm. Sci. Technol. 2008, 62 (S-4), 1–62.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  2. 2.↵
    1. DiLeo A. J.,
    2. Vacante D.,
    3. Deane E. F.
    Size exclusion removal of model viruses using a unique membrane system. Part II: Module qualification and process stimulation. Biologicals 1993, 21 (3), 287–296.
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  3. 3.↵
    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 bioprocessing. Biotechnol. Appl. Biochem. 2005, 84 (2): 179–186.
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  4. 4.↵
    1. Lutz H.,
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    5. Parella J.,
    6. Fisher J.,
    7. Gefroh E.
    Qualification of a novel inline spiking method for virus filter validation. Biotechnol. Prog. 2011, 27 (1), 121–128.
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  5. 5.↵
    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.,
    9. Ruffing M.,
    10. Roiz 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 TextGoogle Scholar
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 68 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 3
May/June 2014
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Meeting Report—Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michael Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 215-220; DOI: 10.5731/pdajpst.2014.00981
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    • 1. Introduction
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  • Meeting Report: 2015 PDA Virus & TSE Safety Forum
  • Knowledge Management and ICH
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Meeting Report—Workshop on Spike Characterizations and Virus Removal by Filtration: Trends and New Developments
Hannelore Willkommen, Johannes Blümel, Kurt Brorson, Dayue Chen, Qi Chen, Albrecht Gröner, Brian R. Hubbard, Thomas R. Kreil, Michael Ruffing, Sol Ruiz, Dorothy Scott, Glenda Silvester
PDA Journal of Pharmaceutical Science and Technology May 2014, 68 (3) 215-220; DOI: 10.5731/pdajpst.2014.00981

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