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

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 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{at}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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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.

Author Information

Xiaolin Cao1,*,
Gregory Stimpfl2,
Zai-qing Wen1,
Gregory Frank2 and
Glenn Hunter2

¹Department of Drug Product Development, Amgen Inc., Thousand Oaks, CA 91320 and
²Department of Pilot Plant Operations, Amgen Inc., Thousand Oaks, CA 91320

↵* Corresponding author: xiaolinc{at}amgen.com

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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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