Session 2/3: Integrated Viral Clearance Strategy and Case Studies

References

1. 1.↵
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   1. Miesegaes G. R.,
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   Analysis of viral clearance unit operations for monoclonal antibodies. Biotechnol. Bioeng. 2010, 106 (2), 238-246.

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   Proceedings of the 2011 Viral Clearance Symposium (South San Francisco, CA). PDA J. Pharm. Sci. Technol. 2014, 68 (1), 1.

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6. 6.↵
   1. Miesegaes G. R.,
   2. Lute S.,
   3. Brorson K.

   Analysis of viral clearance operations for monoclonal antibodies. Biotechnol. Bioeng. 2010, 106 (2), 238–246.

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7. 7.↵
   1. Strauss D. M.,
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   6. Blank G. S.,
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   8. Chen Q.,
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   Understanding the mechanism of virus removal by Q sepharose fast flow chromatography during the purification of CHO-cell derived biotherapeutics. Biotechnol. Bioeng. 2009, 104 (2), 371–380.

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   A novel, Q-PCR based approach to measuring endogenous retroviral clearance by capture protein A chromatography. Biotechnol. Bioeng. 2009, 102 (5), 1438–1447.

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10. 10.↵
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11. 11.↵
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12. 12.↵
    1. Roush D.

    Viral clearance using traditional, well-understood unit operations (Session I): Anion exchange chromatography (AEX). PDA J. Pharm. Sci. Technol. 2014, 68 (1), 23–29

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13. 13.↵
    1. Lower R.,
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14. 14.↵
    ICH Q5A: Quality of biotechnology products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. www.ICH.org.
15. 15.
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    Identification and quantitation of vesivirus 2117 particles in bioreactor fluids from infected Chinese hamster ovary cell cultures. Biotechnol. Bioeng. 2013, 110 (5), 1342–1353.

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