Microbial control within biopharmaceutical manufacturing is a critical quality control to help ensure drug products are free from viable microorganisms. Per regulatory guidelines, the implementation of an environmental monitoring program is required to comply with good manufacturing practices and identification of microorganisms to species level is a minimal requirement. Regulatory agencies consider genotypic identification to be more reliable than phenotypic methods.
Used in top pharmaceutical companies worldwide, the Applied Biosystems MicroSEQ Rapid Microbial Identification System is ideal for environmental monitoring, contamination investigation, root cause analysis, raw materials testing, and microbial identification in small-molecule and biopharmaceutical manufacturing, and service laboratories. The MicroSEQ Rapid Microbial ID System combines the benefits of PCR and DNA sequencing technologies to enable highly accurate results.
“Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic techniques. These methods are especially valuable for investigations into failures (e.g., sterility test; media fill contamination).”
U.S. Food and Drug Administration. Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. U.S. Food and Drug Administration. FDA, October 2004.
The MicroSEQ Rapid Microbial Identification System, based on comparative rDNA sequencing of the 16S region (for bacteria) or the LSU D2 region (for fungi), is a proven genotypic method for rapid and accurate microbial identification.
With the MicroSEQ System, right-the-first-time results can be obtained rapidly, using a logical workflow that requires minimum hands-on time. A single, standardized procedure is used for identifying both bacterial and fungal isolates, giving you results from colony to identification in less than 5 hours.
The MicroSEQ Rapid Microbial ID System includes PCR and sequencing kits, a PCR thermal cycler, and a genetic analyzer, the MicroSEQ ID software, and gene libraries. Choose your desired genetic analyzer based on your throughput requirements—no matter the number of samples you need to process, we have you covered.
Our kits, instruments, and software offer an integrated platform solution for your microbial identification needs. Everything you need—including technical assistance and implementation support—available from one source.
After growing the culture, DNA from the culture is extracted. Next, a PCR is performed to obtain template for the sequencing step. Purification kits are used to clean up templates after PCR and sequencing. After sequencing, the organism is identified using MicroSEQ ID library and software.
|Time: 13 mins.
|Time: 28 mins.
|Time: 65 mins.
|Time: 135 mins.
|Time: ~5 mins.
|Isolate genomic DNA from samples
|Execute amplification run and PCR clean-up
|Run cycle sequencing and clean-up
Initiate genetic analysis
|Run microbial identification software
|SeqStudio QST and
SeqStudio Flex PA
The utilization of microorganism identification through DNA sequencing provides an in-depth and comprehensive view of the variety of organisms that may pose a risk to controlled environments or final product. This webinar discusses the standards requiring characterization, identification, and techniques of a genotypic microbial identification method.
Brochure:MicroSEQ Microbial Identification System
Flyer:MicroSEQ ID IQ/OQ Service, Implementation & Training
Product information:MicroSEQ ID Purification Combo Kit v2.0
Application note:Microbial identification using the MicroSEQ system on the SeqStudio Genetic Analyzer
For Research Use Only. Not for use in diagnostic procedures.