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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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Abstract

Leptospira licerasiae, a novel bacterial contaminant found in Genentech cell culture manufacturing operations, poses a challenge to current microbial control strategies in upstream cell culture processes, as this microorganism is fully capable of passing through 0.1 μm sterilizing-grade filtration and is not detectable by standard microbiological methods described in major pharmaceutical compendia for microbial screening and quantification required for release of raw materials, in-process intermediates, and finished products in biopharmaceutical production. The root cause investigation was greatly aided by the genetic identification of the contaminant and subsequent confirmation by cultural method and real-time polymerase chain reaction assay from the affected product batches. The purpose of this case study is to share knowledge on the novel contaminant, L. licerasiae, and potential routes of contamination in the cell culture manufacturing environment from a series of investigations involving root cause analysis, impact assessments, risk assessment, and global corrective and preventative action, as well as to provide guidance on the detection and prevention of Leptospira contamination with the intent to aid the industry to continually improve microbial control strategies for the benefit of patients.

LAY ABSTRACT: Leptospira licerasiae, a novel bacterial contaminant found in cell culture manufacturing operations, poses a challenge to current microbial control strategies in upstream cell culture processes because this microorganism is capable of passing through 0.1 μm sterilizing-grade membrane filters and is not detectable by standard microbiological methods used in biopharmaceutical production. The root cause investigation was greatly aided by the genetic identification of the contaminant and subsequent confirmation by cultural method and real-time polymerase chain reaction assay from the affected product batches. The purpose of this case study is to share knowledge on the novel contaminant, L. licerasiae, and potential routes of contamination in the cell culture manufacturing environment from a series of investigations to provide the industry with guidance on the detection and prevention of Leptospira contamination.

  • Bioreactor contamination
  • Corrective and preventative action
  • Chinese Hamster Ovary cell culture
  • Leptospira licerasiae
  • Polymerase chain reaction
  • Seed train bioreactor
  • © PDA, Inc. 2012
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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
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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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