Microbial Identification
Microbial Identification for Supporting cGMP EM program
The 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).
