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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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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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