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Case ReportCase Studies

Case Study: A Novel Bacterial Contamination in Cell Culture Production—Leptospira licerasiae

Joseph Chen, Jesse Bergevin, Robert Kiss, Gordon Walker, Todd Battistoni, Patricia Lufburrow, Harry Lam and Anders Vinther
PDA Journal of Pharmaceutical Science and Technology November 2012, 66 (6) 580-591; DOI: https://doi.org/10.5731/pdajpst.2012.00892
Joseph Chen
Genentech, Inc., San Francisco, CA
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  • For correspondence: chen.joseph@gene.com
Jesse Bergevin
Genentech, Inc., San Francisco, CA
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Robert Kiss
Genentech, Inc., San Francisco, CA
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Gordon Walker
Genentech, Inc., San Francisco, CA
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Todd Battistoni
Genentech, Inc., San Francisco, CA
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Patricia Lufburrow
Genentech, Inc., San Francisco, CA
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Harry Lam
Genentech, Inc., San Francisco, CA
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Anders Vinther
Genentech, Inc., San Francisco, CA
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Article Information

vol. 66 no. 6 580-591
DOI 
https://doi.org/10.5731/pdajpst.2012.00892
PubMed 
23183653

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online November 26, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Joseph Chen*,
  2. Jesse Bergevin,
  3. Robert Kiss,
  4. Gordon Walker,
  5. Todd Battistoni,
  6. Patricia Lufburrow,
  7. Harry Lam and
  8. Anders Vinther
  1. Genentech, Inc., San Francisco, CA
  1. ↵* Correspondence author: Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990. E-mail: chen.joseph{at}gene.com. Phone: (650) 225-3492
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PDA Journal of Pharmaceutical Science and Technology: 66 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 6
November/December 2012
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Case Study: A Novel Bacterial Contamination in Cell Culture Production—Leptospira licerasiae
Joseph Chen, Jesse Bergevin, Robert Kiss, Gordon Walker, Todd Battistoni, Patricia Lufburrow, Harry Lam, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 580-591; DOI: 10.5731/pdajpst.2012.00892

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Case Study: A Novel Bacterial Contamination in Cell Culture Production—Leptospira licerasiae
Joseph Chen, Jesse Bergevin, Robert Kiss, Gordon Walker, Todd Battistoni, Patricia Lufburrow, Harry Lam, Anders Vinther
PDA Journal of Pharmaceutical Science and Technology Nov 2012, 66 (6) 580-591; DOI: 10.5731/pdajpst.2012.00892
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  • Article
    • Abstract
    • Introduction
    • Contamination Background
    • Characteristics of the Contaminant
    • Nutrient Requirement and CHO Cell Dependency
    • Root Cause Analysis
    • Impact Assessment
    • Risk Assessment
    • Risk Control Strategies Considered
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
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More in this TOC Section

  • Phase-Incremental Decision Trees for Multi-Phase Feature Selection and Interaction in Biologics Manufacturing
  • Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment
  • A Risk Assessment and Risk Based Approach Review of Pre-use/Post Sterilization Integrity Testing (PUPSIT)
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Keywords

  • Bioreactor contamination
  • Corrective and preventative action
  • Chinese Hamster Ovary cell culture
  • Leptospira licerasiae
  • Polymerase chain reaction
  • Seed train bioreactor

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