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Research ArticleConference Proceeding

Session 2: Company-Specific Data on Cycled Resin Testing

Johannes Blümel and Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology September 2016, 70 (5) 428-442; DOI: https://doi.org/10.5731/pdajpst.2016.006924
Johannes Blümel
1Paul-Ehrlich-Institut, Virology Department, Paul-Ehrlich-Strasse 51-59, Langen 63225, Germany; and
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  • For correspondence: Johannes.Bluemel@pei.de
Kurt Brorson
2Office of Biotechnology Products, CDER/FDA. 10903 New Hampshire Ave., Silver Spring, MD 20903; (301) 796-2193;
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  • For correspondence: Kurt.Brorson@fda.hhs.gov
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References

  1. 1.↵
    International Conference on Harmonisation (ICH). Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; Q5A(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, 1998. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5A_R1/Step4/Q5A_R1__Guideline.pdf.
  2. 2.↵
    1. Remington K. M.
    Fundamentals Of Viral Clearance Studies Part 4 – Considerations For Evaluating Viral Clearance By Chromatography Steps. Bioresearch Online 2013, 1–2.
  3. 3.↵
    1. Brorson K.,
    2. Brown J.,
    3. Hamilton E.,
    4. Stein K. E.
    Identification of Protein A Media Performance Attributes That Can Be Monitored as Surrogates for Retrovirus Clearance during Extended Re-use. J. Chromatogr. A 2003, 989 (1), 155–163.
    OpenUrlPubMed
  4. 4.↵
    1. Lute S.,
    2. Norling L.,
    3. Hanson M.,
    4. Emery R.,
    5. Stinson D.,
    6. Padua K.,
    7. Blank G.,
    8. Chen Q.,
    9. Brorson K.
    Robustness of Virus Removal by Protein A Chromatography Is Independent of Media Lifetime. J. Chromatogr. A 2008, 1205 (1-2), 17–25.
    OpenUrlPubMed
  5. 5.↵
    1. Zhang M.,
    2. Lute S.,
    3. Norling L.,
    4. Hong C.,
    5. Safta A.,
    6. O'Connor D.,
    7. Bernstein L. J.,
    8. Wang H.,
    9. Blank G.,
    10. Brorson K.,
    11. Chen Q.
    A Novel, Q-PCR Based Approach to Measuring Endogenous Retroviral Clearance by Capture Protein A Chromatography. Biotechnol. Bioeng. 2009, 102 (5), 1438–1447.
    OpenUrlPubMed
  6. 6.↵
    1. Kelley B. D.,
    2. Tannatt M.,
    3. Magnusson R.,
    4. Hagelberg S.,
    5. Booth J.
    Development and Validation of an Affinity Chromatography Step Using a Peptide Ligand for cGMP Production of Factor VIII. Biotechnol. Bioeng. 2004, 87 (3), 400–412.
    OpenUrlPubMed
  7. 7.↵
    1. Morrica A.,
    2. Nardini C.,
    3. Falbo A.,
    4. Bailey A. C.,
    5. Bucci E.
    Manufacturing Process of Anti-thrombin III Concentrate: Viral Safety Validation Studies and Effect of Column Re-use on Viral Clearance. Biologicals 2003, 31 (3), 165–173.
    OpenUrlCrossRefPubMed
  8. 8.↵
    1. Andersson I.,
    2. Connor S. E.,
    3. Lindquist L. O.,
    4. Watson E. A.
    Validation Study for the Removal/Inactivation of Viruses during a Chromatographic Purification Process for Albumin and IgG. 24th Conference of the International Society of Blood Transfusion, 1996.
  9. 9.↵
    1. Xie Y.-W.,
    2. Chan P. K.,
    3. Szeto C. K.,
    4. Kwok S. Y.,
    5. Chu I. M.,
    6. Chu S. S.,
    7. Cheung J. L.,
    8. Wong S. W.,
    9. Ali M.
    B; Wong, B. L. Clearance of Dengue Virus in the Plasma-derived Therapeutic Proteins. Transfusion 2008, 48 (7), 1342–1347.
    OpenUrl
  10. 10.↵
    1. Norling L.,
    2. Lute S.,
    3. Emery R.,
    4. Khuu W.,
    5. Voisard M.,
    6. Xu Y.,
    7. Chen Q.,
    8. Blank G.,
    9. Brorson K.
    Impact of Multiple Re-use of Anion-Exchange Chromatography Media on Virus Removal. J. Chromatogr. A 2005, 1069 (1), 79–89.
    OpenUrlPubMed
  11. 11.↵
    1. Kelley B. D.,
    2. Jakubik J.,
    3. Vicik S.
    Viral Clearance Studies on New and Used Chromatography Resins: critical Review of a Large Dataset. Biologicals 2008, 36 (2), 88–98.
    OpenUrlPubMed
  12. 12.↵
    1. Curtis S.,
    2. Lee K.,
    3. Blank G. S.,
    4. Brorson K.,
    5. Xu Y.
    Generic/Matrix Evaluation of SV40 Clearance by Anion Exchange Chromatography in Flow-through Mode. Biotechnol. Bioeng. 2003, 84 (12), 179–186.
    OpenUrlPubMed
  13. 13.↵
    1. Bach J.,
    2. Connell-Crowly L.
    Clearance of the Rodent Retrovirus, XMuLV, by Protein A Chromatography. Biotechnol. Bioeng. 2014, 112 (4), 743–750.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 70 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 5
September/October 2016
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Session 2: Company-Specific Data on Cycled Resin Testing
Johannes Blümel, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 428-442; DOI: 10.5731/pdajpst.2016.006924

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Session 2: Company-Specific Data on Cycled Resin Testing
Johannes Blümel, Kurt Brorson
PDA Journal of Pharmaceutical Science and Technology Sep 2016, 70 (5) 428-442; DOI: 10.5731/pdajpst.2016.006924
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Jump to section

  • Article
    • Background
    • Review of Viral Clearance Strategies for Cycled Chromatography Resins (Glen Bolton; Amgen)
    • Optimization of Viral Clearance Strategies (Martina Kopp; Amgen)
    • Viral Clearance Studies with New and Cycled Resins at Biogen (Brad Stanley; Biogen)
    • Consistent Virus Clearance in Reuse Resins (L. Norling and Q. Chen; Genentech)
    • An Alternative Approach to Evaluation of Viral Clearance on New versus End-of-Life AEX Chromatography Resin (C. Gallo, A. Sacramo, and S. Sun; Pfizer)
    • Virus Clearance with Chromatography Media Reuse for a mAb Process (E. Wilson; GSK)
    • AEX Resin Aging for Viral Clearance Studies (Richard Chen; Eli Lilly)
    • Impact of Cycled Chromatography Resin on Viral Clearance (K. Cai; MedImmune)
    • Summary
    • References
  • Figures & Data
  • References
  • Info & Metrics
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Cited By...

  • Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies--A Multiple Company Collaboration
  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
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More in this TOC Section

  • Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies
  • Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation
  • Proceedings of the 2017 Viral Clearance Symposium: Conclusion
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