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Research ArticleResearch

The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim

Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg and John Schreffler
PDA Journal of Pharmaceutical Science and Technology November 2019, 73 (6) 552-561; DOI: https://doi.org/10.5731/pdajpst.2019.010116
Dwaine Banton
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
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Dominick Vacante
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
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Ben Bulthuis
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
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Josh Goldstein
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
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Michael Wineburg
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
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John Schreffler
Janssen R and D, 200 Great Valley Parkway, Malvern, PA 19355
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  • For correspondence: jschreff@its.jnj.com
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References

  1. 1.↵
    International Conference for Harmonisation, ICH Harmonized Tripartite Guideline: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A (R1), Step 4 Version, ICH Geneva, 1999.
    Google Scholar
  2. 2.↵
    1. Miesegaes G.,
    2. Lute S.,
    3. Brorson K.
    Analysis of Viral Clearance Unit Operations for Monoclonal Antibodies. Biotechnol. Bioeng. 2010, 106 (2), 238–246.
    OpenUrlPubMedGoogle Scholar
  3. 3.↵
    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. (Basel, Switz.) 2010, 133, 3–101.
    OpenUrlGoogle Scholar
  4. 4.↵
    1. Edwards J.,
    2. Mann E.,
    3. Brown D. T.
    Conformational Changes in Sindbis Virus Envelope Proteins Accompanying Exposure to Low pH. J. Virol. 1983, 45 (3), 1090–1097.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  5. 5.↵
    1. Brorson K.,
    2. Krejci S.,
    3. Lee K.,
    4. Hamilton E.,
    5. Stein K.,
    6. 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.
    OpenUrlCrossRefPubMedGoogle Scholar
  6. 6.↵
    1. Vacante D.,
    2. Connell-Crowley L.
    Protocol for Evaluation of Virus Inactivation Using Low-pH Treatment. PDA J. Pharm. Sci. Technol. 2014, 68 (1), 90–97.
    OpenUrlFREE Full TextGoogle Scholar
  7. 7.↵
    1. Mattila J.,
    2. Clark M.,
    3. Liu S.,
    4. Pieracci J.,
    5. Gervais T. R.,
    6. Wilson E.,
    7. Galperina O.,
    8. Li X.,
    9. Roush D.,
    10. Zoeller K.,
    11. Brough H.,
    12. Simpson-Platre C.
    Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration. PDA J. Pharm. Sci. Technol. 2016, 70 (3), 293–299.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
  8. 8.↵
    1. Chinniah S.,
    2. Hinckley P.,
    3. Connell-Crowley L.
    Characterization of Operating Parameters for MuLV Inactivation by Low pH Treatment. Biotechnol. Prog. 2016, 32 (1), 89–97.
    OpenUrlGoogle Scholar
  9. 9.↵
    U.S. Food and Drug Administration. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 1997.
    Google Scholar
  10. 10.↵
    1. Strauss D. M.,
    2. Cano T.,
    3. Cai N.,
    4. Delucchi H.,
    5. Plancarte M.,
    6. Coleman D.,
    7. Blank G. S.,
    8. Chen Q.,
    9. Yang B.
    Strategies for Developing Design Spaces for Viral Clearance by Anion Exchange Chromatography during Monoclonal Antibody Production. Biotechnol. Prog. 2010, 26 (3), 750–755.
    OpenUrlPubMedGoogle Scholar
  11. 11.↵
    1. Stuckey J.,
    2. Strauss D.,
    3. Venkiteshwaran A.,
    4. Gao J.,
    5. Luo W.,
    6. Quertinmont M.,
    7. O'Donnell S.,
    8. Chen D.
    A Novel Approach to Achieving Modular Retrovirus Clearance for a Parvovirus Filter. Biotechnol. Prog. 2014, 30 (1), 79–85.
    OpenUrlCrossRefGoogle Scholar
  12. 12.↵
    ASTM Standard E 2888: Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. In ASTM Volume 14.05 Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical and Biopharmaceutical Products [Online]; ASTM International: West Conshohocken, PA, 2012.
    Google Scholar
  13. 13.↵
    1. Iskra T.,
    2. Sacramo A.,
    3. Gallo C.,
    4. Godavarti R.,
    5. Chen S.,
    6. Lute S.,
    7. Brorson K.
    Development of a Modular Virus Clearance Package for Anion Exchange Chromatography Operated in Weak Partitioning Mode. Biotechnol. Prog. 2015, 31 (3), 750–757.
    OpenUrlGoogle Scholar
  14. 14.↵
    1. Durno L.,
    2. Tounekti O.
    Viral Inactivation: Low pH and Detergent. PDA J. Pharm. Sci. Technol. 2015, 69 (1), 163–172.
    OpenUrlFREE Full TextGoogle Scholar
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PDA Journal of Pharmaceutical Science and Technology: 73 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 6
November/December 2019
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The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg, John Schreffler
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 552-561; DOI: 10.5731/pdajpst.2019.010116
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Keywords

  • Viral inactivation
  • Modular viral clearance
  • Modular claim
  • Generic claim
  • Low pH inactivation
  • Viral clearance
  • Log reduction value (LRV)
  • Murine leukemia virus (MuLV)
  • Retrovirus
  • Viral Safety

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The Use of Bayesian Hierarchical Logistic Regression in the Development of a Modular Viral Inactivation Claim
Dwaine Banton, Dominick Vacante, Ben Bulthuis, Josh Goldstein, Michael Wineburg, John Schreffler
PDA Journal of Pharmaceutical Science and Technology Nov 2019, 73 (6) 552-561; DOI: 10.5731/pdajpst.2019.010116

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