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Case ReportCase Studies

Identification and Root Cause Analysis of Cell Culture Media Precipitates in the Viral Deactivation Treatment with High-Temperature/Short-Time Method

Xiaolin Cao, Gregory Stimpfl, Zai-qing Wen, Gregory Frank and Glenn Hunter
PDA Journal of Pharmaceutical Science and Technology January 2013, 67 (1) 63-73; DOI: https://doi.org/10.5731/pdajpst.2013.00894
Xiaolin Cao
1Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA 91320 and
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  • For correspondence: xiaolinc@amgen.com
Gregory Stimpfl
2Department of Pilot Plant Operations, Amgen Inc., Thousand Oaks, CA 91320
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Zai-qing Wen
1Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA 91320 and
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Gregory Frank
2Department of Pilot Plant Operations, Amgen Inc., Thousand Oaks, CA 91320
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Glenn Hunter
2Department of Pilot Plant Operations, Amgen Inc., Thousand Oaks, CA 91320
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Article Information

vol. 67 no. 1 63-73
DOI 
https://doi.org/10.5731/pdajpst.2013.00894
PubMed 
23385565

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 5, 2013.

Copyright & Usage 
© PDA, Inc. 2013

Author Information

  1. Xiaolin Cao1,*,
  2. Gregory Stimpfl2,
  3. Zai-qing Wen1,
  4. Gregory Frank2 and
  5. Glenn Hunter2
  1. 1Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA 91320 and
  2. 2Department of Pilot Plant Operations, Amgen Inc., Thousand Oaks, CA 91320
  1. ↵* Corresponding author: xiaolinc{at}amgen.com
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PDA Journal of Pharmaceutical Science and Technology: 67 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 1
January/February 2013
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Identification and Root Cause Analysis of Cell Culture Media Precipitates in the Viral Deactivation Treatment with High-Temperature/Short-Time Method
Xiaolin Cao, Gregory Stimpfl, Zai-qing Wen, Gregory Frank, Glenn Hunter
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 63-73; DOI: 10.5731/pdajpst.2013.00894

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Identification and Root Cause Analysis of Cell Culture Media Precipitates in the Viral Deactivation Treatment with High-Temperature/Short-Time Method
Xiaolin Cao, Gregory Stimpfl, Zai-qing Wen, Gregory Frank, Glenn Hunter
PDA Journal of Pharmaceutical Science and Technology Jan 2013, 67 (1) 63-73; DOI: 10.5731/pdajpst.2013.00894
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Keywords

  • Cell culture media
  • Viral contamination mitigation
  • High-temperature/short-time (HTST)
  • Media precipitation
  • Metal phosphates
  • Root cause analysis

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