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Used in top pharmaceutical companies worldwide, the Applied Biosystems MicroSEQ Rapid Microbial Identification System is an ideal solution 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.
Accurate identification of isolates is required to support active environmental monitoring programs within pharmaceutical manufacturing facilities and to implement accurate Corrective and Preventive Actions (CAPAs) for products and processes to help reduce the risk of contamination. The comparative gene sequence analysis of ribosomal DNA (rDNA) has been shown to have the highest accuracy of microbial identification system technologies and has been considered the widely-trusted standard for microbial identification for over a decade.
The Applied Biosystems 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 widely-used genotypic method for rapid and accurate microbial identification.
“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 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.
Streamlining every step in the microbial identification process, the MicroSEQ System combines the advantages of MicroSEQ ID Software with easy sample preparation reagents and protocols, MicroSEQ bacterial and fungal application kits, and trusted thermal cyclers and sequencing systems. To facilitate optimal performance and system-wide integration, we develop and test all components of the system together.
A single, standardized procedure is used for identifying both bacterial and fungal isolates, giving you results from colony to identification in less than five hours.
The Applied Biosystems PrepMan Ultra Sample Preparation Reagent was developed for the rapid preparation of DNA template from gram-negative pathogens for use in PCR amplification reactions. It has been used to prepare PCR-ready template from a wide variety of different sources, including bacteria, yeast, filamentous fungi, from a plate or from liquid culture, mammalian tissue smears, human cells (buccal swab), and mammalian whole blood. It offers a simple rapid protocol, helping reduce time-to-results.
Specific and easy-to-use, MicroSEQ kits provide all the reagents needed for robust microbial identification. Complementary PCR and Sequencing kits have been tested and internally validated to meet or exceed regulatory guidelines. There are several kits and corresponding data libraries to choose from—covering more than 12,000 strain types of bacteria and fungi.
The Applied Biosystems VeritiPro Thermal Cycler offers proven reliability with advanced temperature control technology and connectivity. Take advantage of next-level PCR optimization with the precision offered by VeriFlex temperature control technology.
The Applied Biosystems SeqStudio Series of genetic analyzers offer the high quality and reliable performance of Sanger sequencing and fragment analysis that scientists need, while leveraging design improvements and technological advances for increased flexibility, easier operation, enhanced connectivity, and remote serviceability.
Unlock the power of precise bacterial and fungal sequence identification with MicroSEQ Identification Software 4.0, tailored for the Applied Biosystems SeqStudio genetic analyzers. Experience advanced analysis, packed with features that elevate your workflow while supporting compliance with 21 CFR Part 11 regulatory standards.
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