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Research ArticleConference Proceeding - Article

Viral Clearance by Traditional Operations With Significant Knowledge Gaps (Session II): Cation Exchange Chromatography (CEX) and Detergent Inactivation

George Miesegaes
PDA Journal of Pharmaceutical Science and Technology January 2014, 68 (1) 30-37; DOI: https://doi.org/10.5731/pdajpst.2014.00964
George Miesegaes
Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)
Ph.D.
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References

  1. 1.↵
    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) 2010, 133, 3–101.
    OpenUrlPubMed
  2. 2.↵
    1. Connell-Crowley L.,
    2. Nguyen T.,
    3. Bach J.,
    4. Chinniah S.,
    5. Bashiri H.,
    6. Gillespie R.,
    7. Moscariello J.,
    8. Hinckley P.,
    9. Dehghani H.,
    10. Vunnum S.,
    11. Vedantham G.
    Cation exchange chromatography provides effective retrovirus clearance for antibody purification processes. Biotechnol. Bioeng. 2012, 109 (1), 157–165.
    OpenUrlPubMed
  3. 3.↵
    1. Miesegaes G.,
    2. Lute S.,
    3. Brorson K.
    Analysis of viral clearance unit operations from monoclonal antibody regulatory submissions. Biotechnol. Bioeng. 2010, 106 (2), 238–246.
    OpenUrlPubMed
  4. 4.↵
    1. Miesegaes G. R.,
    2. Lute S.,
    3. Strauss D. M.,
    4. Read E. K.,
    5. Venkiteshwaran A.,
    6. Kreuzman A.,
    7. Shah R.,
    8. Shamlou P.,
    9. Chen D.,
    10. Brorson K.
    Monoclonal antibody capture and viral clearance by cation exchange chromatography. Biotechnol. Bioeng. 2012, 109 (8), 2048–2058.
    OpenUrlPubMed
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PDA Journal of Pharmaceutical Science and Technology: 68 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 1
January/February 2014
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Viral Clearance by Traditional Operations With Significant Knowledge Gaps (Session II): Cation Exchange Chromatography (CEX) and Detergent Inactivation
George Miesegaes
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 30-37; DOI: 10.5731/pdajpst.2014.00964

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Viral Clearance by Traditional Operations With Significant Knowledge Gaps (Session II): Cation Exchange Chromatography (CEX) and Detergent Inactivation
George Miesegaes
PDA Journal of Pharmaceutical Science and Technology Jan 2014, 68 (1) 30-37; DOI: 10.5731/pdajpst.2014.00964
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  • Article
    • CEX Background
    • MuLV Removal by CEX Chromatography (Lisa Connell-Crowley, Amgen)
    • Evaluation of CEX as a Capture Step for mAb Purification (G. Miesegaes, CDER/FDA)
    • Detergent Inactivation Background
    • Virus Inactivation by Detergents (L. Norling; Genentech, a Member of the Roche Group)
    • References
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Cited By...

  • Viral Inactivation: Low pH and Detergent
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More in this TOC Section

  • Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Low-pH Inactivation
  • Viral Clearance by Traditional Operations with Significant Knowledge Gaps (Session II): Protein A Chromatography
  • Viral Clearance Using Traditional, Well-Understood Unit Operations (Session I): Anion Exchange Chromatography (AEX)
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