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Research ArticleProceedings of the 2017 Viral Clearance Symposium

Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime

Johannes Blümel and Junfen Ma
PDA Journal of Pharmaceutical Science and Technology September 2018, 72 (5) 488-497; DOI: https://doi.org/10.5731/pdajpst.2018.009134
Johannes Blümel
1Virology Department, Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, Langen 63225, Germany; and
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  • For correspondence: Johannes.Bluemel@pei.de
Junfen Ma
2Shire, 300 Shire Way, Lexington, MA 02421, USA
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Abstract

In many downstream processes, chromatographic purification steps contribute significantly to the overall virus reduction capacity. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q5A(R1) outlines that “Over time and after repeated use, the ability of chromatography columns and other devices used in the purification scheme to clear virus may vary. Some estimate of the stability of the viral clearance after several uses may provide support for repeated use of such columns.” Virus reduction studies with used resin normally require a high amount of in-process material and time. The experience with used resin has been accumulated continuously, stimulating the discussion on whether it would be necessary to investigate virus reduction on used resins for each product. In this session, additional experience from studies with used resins was provided.

LAY ABSTRACT: In many downstream processes, chromatographic purification steps contribute significantly to the overall virus reduction capacity. An estimate of the stability of the viral clearance after several uses may provide support for repeated use of such columns. Virus reduction studies with used resin normally require a high amount of in-process material and time. The experience with used resin has been accumulated continuously, stimulating the discussion on whether it would be necessary to investigate virus reduction on used resins for each product. In this session, additional experience from studies with used resins was provided.

  • Viral clearance
  • Downstream processing
  • Chromatography
  • Resin lifetime
  • Regulatory perspective
  • © PDA, Inc. 2018
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PDA Journal of Pharmaceutical Science and Technology: 72 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 5
September/October 2018
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Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
Johannes Blümel, Junfen Ma
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 488-497; DOI: 10.5731/pdajpst.2018.009134

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Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
Johannes Blümel, Junfen Ma
PDA Journal of Pharmaceutical Science and Technology Sep 2018, 72 (5) 488-497; DOI: 10.5731/pdajpst.2018.009134
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  • Article
    • Abstract
    • Background
    • Evaluation of Performance Attributes Supporting Maintained Viral Clearance By Chromatography Columns At End of Lifetime
    • John Mattila, Regeneron
    • Review of Viral Clearance Capacity of Used Chromatography Resins In Biologics Purification Processes
    • Glen Bolton, Amgen
    • Evaluation of Virus Carryover and Lifetime In Non-platform Process
    • Shohei Kobayashi, Chugai Pharmaceutical Co., LTD
    • Virus Clearance By Chromatograph: Resin Lifetime and Carryover Studies
    • Dayue Chen, Lilly
    • Retrospective Evaluation of Cycled Resin In Viral Clearance Studies—a Multiple Company Collaboration
    • John Mattila, Regeneron Pharmaceuticals Inc.; Mike Clark, AbbVie Inc.; Justin Weaver and Jeremy Pike, Alexion; Bradford Stanley, Biogen; Deqiang Yu, Bristol-Myers Squibb; Eileen Wilson and Olga Galperina, GlaxoSmithKline plc; Xinfang Li, ImmunoGen Inc. (now of MabPlex); David Roush and Scott Tobler, Merck, Sharp and Dohme, Inc.; Sherrie Curtis, Roche; Andreas Flicker and Johanna Kindermann, Shire plc; Norbert Schuelke, Takeda; Richard Whitcombe, UCB
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Proceedings of the 2017 Viral Clearance Symposium

  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
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Conference Proceeding

  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
  • Proceedings of the 2017 Viral Clearance Symposium, Session 1.1: Upstream Mitigation, Part 1—Cell Bank and Bulk Harvest Testing
  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
Show more Conference Proceeding

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Keywords

  • Viral clearance
  • Downstream processing
  • Chromatography
  • Resin lifetime
  • Regulatory perspective

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