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Research ArticleConference Proceedings

Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies

Simon Reitz and Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology July 2022, 76 (4) 297-305; DOI: https://doi.org/10.5731/pdajpst.2021.012677
Simon Reitz
1Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany; and
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Astrid Schwantes
2Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany
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  • For correspondence: Astrid.Schwantes@pei.de
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References

  1. 1.↵
    European Medicines Agency, Guideline on Virus Safety Evaluation of Biotechnological Investigation Medicinal Products. EMA: London, 2008.
  2. 2.↵
    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.
  3. 3.↵
    1. Sipple P.,
    2. Nguyen T.,
    3. Patel K.,
    4. Jaffe N.,
    5. Chen Y.,
    6. Khetan A.
    Suitability of a Generic Virus Safety Evaluation for Monoclonal Antibody Investigational New Drug Applications. Biotechnol. Prog. 2019, 35 (5), e2850.
    OpenUrl
  4. 4.↵
    1. Schwantes A.,
    2. Specht R.,
    3. Chen Q.
    Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies. PDA J. Pharm. Sci. Technol. 2018, 72 (5), 498–510.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. Kreil T. R.,
    2. Roush D.
    Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation. PDA J. Pharm. Sci. Technol. 2018, 72 (5), 470–478.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    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 Text
  7. 7.↵
    ASTM International. ASTM E2888–12 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. ASTM: West Conshohocken, PA, 2012.
  8. 8.↵
    ASTM International. ASTM E3042 Standard Practice for Process Step to Inactivate Rodent Retrovirus with Triton X-100 Treatment. ASTM: West Conshohocken, PA, 2016.
  9. 9.↵
    PDA Virus Filtration Task Force. PDA Technical Report No. 41, Revised 2008: Virus Filtration. PDA J. Pharm. Sci. Technol. 2008, 62 (S-4).
  10. 10.↵
    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.
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  11. 11.↵
    International Conference for Harmonisation, Q5A(R1) Step 5, Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. ICH: Geneva, 1997.
  12. 12.↵
    1. Wulff N. H.,
    2. Tzatzaris M.,
    3. Young P. J.
    Monte Carlo Simulation of the Spearman- Kaerber TCID50. J. Clin. Bioinf. 2012, 2 (1), 5.
    OpenUrl
  13. 13.↵
    European Medicines Agency, Meeting Report: Joint BWP/QWP Workshop with Stakeholders in Relation to Prior Knowledge and Its Use in Regulatory Applications. EMA: London, 2018.
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PDA Journal of Pharmaceutical Science and Technology: 76 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 4
July/August 2022
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Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
Simon Reitz, Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology Jul 2022, 76 (4) 297-305; DOI: 10.5731/pdajpst.2021.012677

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Proceedings of the 2019 Viral Clearance Symposium, Session 1: Viral Clearance Strategies and Case Studies
Simon Reitz, Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology Jul 2022, 76 (4) 297-305; DOI: 10.5731/pdajpst.2021.012677
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  • Proceedings of the 2023 Viral Clearance Symposium: 2023 VCS Summary, Pending Questions, and Next Steps
  • Proceedings of the 2023 Viral Clearance Symposium, Session 1: Regulatory Updates
  • Proceedings of the 2023 Viral Clearance Symposium, Session 4: Continuous Processing
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Keywords

  • Biologic License Application
  • Downstream processing
  • Viral Clearance Symposium
  • Viral clearance
  • Generic/modular claim
  • Recombinant Adeno-Associated virus (rAAV) vectors

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