MDS offers GLP genotypic identification of microbes using DNA sequencing technology as a part of routine environmental monitoring (EM) program for aseptic processing under GMP guidelines (21 CFR 58).
Our clients may provide the environmental samples for initial culturing or identify the EM positive cultures and submit them to MDS. Our scientists will provide the following services:
- DNA isolation from cultures
- PCR amplification of the 16S rRNA gene for bacterial isolates using
- D2 expansion (Large -Subunit , LSU) segment of the 28S rRNA gene for fungal isolates Bi-directional DNA sequencing
- Sequence delineation on ABI PrismT 3730XL DNA sequencer
- Results are analyzed against a validated database of environmental monitoring microbial isolates.