Rapid microbial characterization and identification to support environmental monitoring
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.
MicroSEQ Microbial Identification System
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.
Benefits of the MicroSEQ Rapid Microbial ID System
- Accurate and specific: phylogenetic approach, based on the sequencing of the 16S rRNA gene for bacteria or the D2 region of the large subunit ribosomal DNA for fungi, delivers high discrimination power.
- Regulatory compliant: complies with approaches recommended by regulatory agencies such as ICH, USP, EUP, and JP, for accurate contamination identification.
- Rapid time to results: ~5 hrs from colony to identification, allowing in-process testing.
- Wide range of organisms: software using largest and most comprehensive validated libraries for bacteria and fungi.
- Streamlined workflow: standardized, simple and easy-to-validate workflow.
- Support network: worldwide technical and validation support, detailed training and implementation guidance.
“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.
Integrated platform solution generating actionable results, the first time
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.
Simple workflow
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.
| Extract DNA > | Run PCR > | Cycle sequencing > | Sequence run > | Identify organism |
|---|---|---|---|---|
| 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 |
 |  | |  |  |
| VeritiPro PCR Thermal Cycler | SeqStudio QST and SeqStudio Flex PA genetic analyzers | |||
Reagents: | PCR Reagents: Fast MicroSEQ 500 16S rDNA PCR Kit MicroSEQ Full Gene 16S rDNA PCR Kit Fast MicroSEQ D2 Fungal rDNA PCR Kit Purification kits: MicroSEQ ID Purification Combo Kit v2.0, with clean-up plates | Sequence Reagents: MicroSEQ 500 16S rDNA Sequencing Kit MicroSEQ Full Gene 16S rDNA Sequencing Kit MicroSEQ D2 rDNA Fungal Sequencing Kit Purification kits: MicroSEQ ID Purification Combo Kit v2.0, with clean-up plates | Software: MicroSEQ ID Microbial Identification Software 4.0 Libraries: MicroSEQ ID 16S rDNA 500 Library, v2022 MicroSEQ ID 16S rDNA Full Gene Library, v2.1 |
Webinar: Identification via DNA-Sequencing Methods to Support Risk Mitigation Strategies
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.
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Related resources
Brochures and product information
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
On-demand webinars
- Targeted Sequence Analysis to Propel Biopharmaceutic Development
- Microbial identification via DNA‑sequencing method to support risk mitigation
- Methods for Rapid Microbial Testing and Identification: When and How
- Microbial Identification for All: Exploring the MicroSEQ ID Microbial Identification System
- A Straightforward Path Toward Regulatory Compliance and Data Integrity with Your Microbial Testing Systems
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