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Research ArticleCONFERENCE PROCEEDING

Bacterial Genome Reference Databases: Progress and Challenges

Tom Slezak
PDA Journal of Pharmaceutical Science and Technology November 2014, 68 (6) 619-625; DOI: https://doi.org/10.5731/pdajpst.2014.01017
Tom Slezak
Bioinformatics, Global Security Program, Lawrence Livermore National Lab, Livermore, CA.
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Abstract

Accurate and sensitive detection of microbes against a complex background is a problem common to multiple aspects of human health, such as vaccines and other biologicals safety, blood safety, and diagnosing infectious diseases in humans or other hosts. The microbes in question could be bacterial, viral, fungal, or parasitical. To defend against such a broad array of microbes of potential safety concern, we need more than single-target polymerase chain reaction (PCR) assays. Technologies such as highly-multiplexed PCR, broad-spectrum DNA/RNA microarrays, and next-generation sequencing are all potentiallycapable to provide increased protection against microbial contamination. Regulatory processes are currently struggling to keep up with rapid advances in all of these technologies, each of which is firmly based upon nucleic acid sequencing resulting in generation of megabases of data. A major question is the level of quality required for genomic data and metadata for the reference databases that are needed to allow these technologies to be developed, validated, and then used for front-line protection of human health. The background of this general problem is discussed and one example of an ongoing effort to establish quality levels for a bacterial genome reference database is presented.

  • Genome reference databases
  • Metadata
  • Multiplex-PCR
  • Broad-spectrum microarrays
  • Next-generation sequencing

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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Bacterial Genome Reference Databases: Progress and Challenges
Tom Slezak
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 619-625; DOI: 10.5731/pdajpst.2014.01017

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Bacterial Genome Reference Databases: Progress and Challenges
Tom Slezak
PDA Journal of Pharmaceutical Science and Technology Nov 2014, 68 (6) 619-625; DOI: 10.5731/pdajpst.2014.01017
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  • Article
    • Abstract
    • Introduction
    • Dependence on Genomic Reference Databases
    • Genomic Databases Will Be Required for (Eventual) FDA Device Validation
    • What Does “High-Quality Genomic Bacterial Reference Database” Mean in This Context?
    • Database Curation Is in the Eye of the Beholder
    • Why Aren't Existing Genome Reference Databases Sufficient?
    • What Efforts Are Underway to Develop New Genome Reference Databases?
    • Reference Genomic Database Standards Must Be Practical
    • You Can't Get Retrospective Metadata
    • Experience of a Pilot Bacterial Genome Reference Database Quality Project
    • Summary
    • Footnotes
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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CONFERENCE PROCEEDING

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  • Proceedings of the 2017 Viral Clearance Symposium, Session 3: Resin Lifetime
Show more CONFERENCE PROCEEDING

Bioinformatics and Databases

  • FDA's Activities Supporting Regulatory Application of “Next Gen” Sequencing Technologies
Show more Bioinformatics and Databases

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Keywords

  • Genome reference databases
  • Metadata
  • Multiplex-PCR
  • Broad-spectrum microarrays
  • Next-generation sequencing

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