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Research ArticleCONFERENCE PROCEEDING

Detection of Adventitious Agents Using Next-Generation Sequencing

Brenda Richards, Sherry Cao, Mark Plavsic, Robert Pomponio, Claire Davies, Robert Mattaliano, Stephen Madden, Katherine Klinger and Adam Palermo
PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 651-660; DOI: https://doi.org/10.5731/pdajpst.2014.01025
Brenda Richards
aFunctional Genomics & Science Computing;
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  • For correspondence: brenda.richards@genzyme.com
Sherry Cao
aFunctional Genomics & Science Computing;
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Mark Plavsic
bProcess Engineering Development;
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Robert Pomponio
cClinical Assay Development;
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Claire Davies
dAnalytical Development;
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Robert Mattaliano
eBiologics Research & Development, Genzyme, A Sanofi Company, Framingham, MA, USA
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Stephen Madden
aFunctional Genomics & Science Computing;
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Katherine Klinger
aFunctional Genomics & Science Computing;
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Adam Palermo
aFunctional Genomics & Science Computing;
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Abstract

Next-generation sequencing has been evaluated at Genzyme as a means of identifying bioreactor contaminants due to its capability for detection of known and novel microbial species. In this approach, data obtained from next-generation sequencing is used to interrogate databases containing genomic sequences and identities of potential adventitious agents. We describe here the use of this approach to help identify the causative agent of a bioreactor contamination. We also present the results of spiking experiments to establish the limits of detection for DNA viruses, RNA viruses, and bacteria, in a background of Chinese hamster ovary cells, a cell line used for production of many human therapeutics. Using Illumina sequencing-based detection, all of the viruses included in this study were detected at less than 1 copy per cell, and bacteria were detected at 0.001 copy per cell. Thus, next-generation sequencing–based detection of adventitious agents is a valuable approach that can fill a critical unmet need in the detection of known and novel microorganisms in biopharmaceutical manufacturing.

LAY ABSTRACT: Because biological products are manufactured in cells, the living environment must be kept sterile. Any introduction of microorganisms into the culture vessel may affect the growth and other biological properties of the cells or contaminate the product. It is therefore important to monitor the culture for such contaminants, but many methods can only detect a specific microorganism. In this study, we show that next-generation sequencing–based detection is a sensitive and complementary approach that can potentially detect a wide range of organisms.

  • Next-generation sequencing
  • Limit of detection
  • Adventitious agents
  • Library construction
  • Biosurveillance

Footnotes

  • CONFERENCE PROCEEDING: Proceedings of the PDA/FDA Advanced Technologies for Virus Detection in the Evaluation of Biologicals Conference: Applications and Challenges Workshop in Bethesda, MD, USA; November 13-14, 2013

  • Guest Editors: Arifa S. Khan (Rockville, MD), Dominick Vacante (Malvern, PA)

  • © PDA, Inc. 2014
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PDA Journal of Pharmaceutical Science and Technology: 68 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 6
November/December 2014
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Detection of Adventitious Agents Using Next-Generation Sequencing
Brenda Richards, Sherry Cao, Mark Plavsic, Robert Pomponio, Claire Davies, Robert Mattaliano, Stephen Madden, Katherine Klinger, Adam Palermo
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 651-660; DOI: 10.5731/pdajpst.2014.01025

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Detection of Adventitious Agents Using Next-Generation Sequencing
Brenda Richards, Sherry Cao, Mark Plavsic, Robert Pomponio, Claire Davies, Robert Mattaliano, Stephen Madden, Katherine Klinger, Adam Palermo
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 651-660; DOI: 10.5731/pdajpst.2014.01025
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Keywords

  • Next-generation sequencing
  • Limit of detection
  • Adventitious agents
  • Library construction
  • Biosurveillance

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