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Research ArticleConference Proceedings

Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies

Frank Kohne and Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology March 2024, 78 (2) 147-156; DOI: https://doi.org/10.5731/pdajpst.2024.002242
Frank Kohne
1Boehringer Ingelheim Pharma GmbH & Co. KG, Development Operations Germany/Downstream Development, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany; and
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  • For correspondence: frank.kohne@boehringer-ingelheim.com
Astrid Schwantes
2Paul-Ehrlich-Institut, Virology Department, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany
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References

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    International Conference for Harmonisation. ICH Harmonised Tripartite Guideline Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Step 2, Draft version, Endorsed on 29 September 2022. ICH: Geneva, 2022.
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    Production, Purification and Characterization of Adeno-Associated Vectors. Curr. Gene Ther. 2010, 10 (6), 423–436.
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    Characterizing Clearance of Helper Adenovirus by a Clinical rAAV1 Manufacturing Process. Biologicals 2008, 36 (1), 7–18.
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    1. Bennett A.,
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    Thermal Stability as a Determinant of AAV Serotype Identity. Mol. Ther. Methods Clin. Dev. 2017, 6, 171–182.
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PDA Journal of Pharmaceutical Science and Technology: 78 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 2
March/April 2024
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Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies
Frank Kohne, Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology Mar 2024, 78 (2) 147-156; DOI: 10.5731/pdajpst.2024.002242

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Proceedings of the 2023 Viral Clearance Symposium, Session 2: Viral Clearance Strategy and Case Studies
Frank Kohne, Astrid Schwantes
PDA Journal of Pharmaceutical Science and Technology Mar 2024, 78 (2) 147-156; DOI: 10.5731/pdajpst.2024.002242
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More in this TOC Section

  • Proceedings of the 2023 Viral Clearance Symposium, Session 5: Viral Clearance Strategy and Process Understanding
  • Proceedings of the 2023 Viral Clearance Symposium, Session 8: Cell Banks, Advanced Technologies (ATMPs, NGS)
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Keywords

  • Viral clearance (studies)
  • Prior knowledge
  • Triton CG-110
  • Hydrophobic interaction chromatography
  • Risk assessment tool
  • Adeno-associated viral vectors
  • Heat treatment
  • Helper virus
  • Adenovirus

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