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Microbial Identification for Supporting cGMP EM program

microbial identificationThe Food and Drug Administration (FDA) has recommended genotypic identification of microbes as a part of routine environmental monitoring (EM) program for aseptic processing under cGMP guidelines. ACGT, Inc. offers GLP compliant microbial identification using reliable DNA sequencing technology with the results analyzed against a validated database of EM microbial isolates. We guarantee fast turnaround for urgently needed answers and accurate results.

Service Description:


  • DNA isolates from EM positive cultures. (cultures are identified by the biomanufacturing facility and submitted to ACGT, Inc.)
  • PCR amplification of the 16S rRNA gene for bacterial isolates and D2 expansion segment of the 28S rRNA gene for fungal isolates.
  • Bi-directional DNA sequencing.
  • Sequence delineation on ABI Prism™ 3730XL Genetic Analyzer.
  • Results are analyzed against a validated microbial sequence database.
  • 21 CFR 58 compliant (GLP).

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