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MycoSEQ Mycoplasma Detection System

The Applied Biosystems MycoSEQ Mycoplasma Detection System is a fully integrated, real-time PCR (qPCR) solution for rapid Mycoplasma testing. Used throughout the bioproduction workflow, the MycoSEQ System supports an appealing alternative to time-consuming culture-based tests by helping to deliver accurate and actionable results in about five hours.

 

Backed by  a successful track record of regulatory acceptance, the MycoSEQ System can help simplify Mycoplasma detection for raw material, cell bank, in-process, and lot-release testing.

  • Method accepted by regulatory agencies for Mycoplasma detection in a cGMP environment
  • Requires no live Mycoplasma for testing or process validation
  • Total workflow solution, from sample prep to analysis with SAE compatible software
  • Detection of all recommended species listed in European, US, and Japanese pharmacopeias
  • Supported throughout the validation process 

Rapid Mycoplasma Testing Method for Lot-Release

Learn how the MycoSEQ Drug Master File can
assist in regulatory acceptance of the method


Simple qPCR workflow

The complete MycoSEQ Mycoplasma Detection System is an integrated, real-time PCR (qPCR) solution for rapid mycoplasma testing. Comprised of functionally confirmed sample-to-answer protocols, commercially available kits for sample preparation and qPCR, and instruments with analytical software to help enable regulatory compliance, the MycoSEQ workflow enables a flexible approach to meet a variety of Mycoplasma testing applications.

 


Superior Mycoplasma extraction

PrepSEQ 1-2-3 Mycoplasma Nucleic Acid Extraction Kit

Optimized for use with MycoSEQ Mycoplasma Detection Kits, the PrepSEQ 1-2-3 Mycoplasma Nucleic Acid Extraction Kit uses proprietary magnetic bead–based separation technology to extract Mycoplasma DNA from mammalian cell lines. The PrepSEQ 1-2-3 kit extracts Mycoplasma genomic DNA from research cell lines, stem cell lines, and cellular and tissue therapy samples with high efficiency and high recovery—helping to deliver results in under 2 hours.

AutoMate Express Nucleic Acid Extraction System

An easy-to-use benchtop instrument enables hands-free automation of the nucleic acid extraction process for the MycoSEQ Mycoplasma detection workflow. The instrument uses the established PrepSEQ nucleic acid extraction chemistry packaged into a cartridge format for quantitative recovery of DNA and RNA. The AutoMate Express system offers out-of-the-box automation for easy integration into existing workflows and lab configurations. There is minimal hands-on time with this closed system—just load and go with prefilled reagent cartridges and preprogrammed protocols.


Rapidly detect Mycoplasmas with confidence

Core to the MycoSEQ System are its high-performance assay kits. MycoSEQ Mycoplasma detection kits are available in both probe-based and dye-based formulations to enable optimum performance, regardless of sample matrices. With a long track record of validation, MycoSEQ Solutions have been accepted worldwide as meeting regulatory guidelines for the detection of Mycoplasmas across multiple therapeutic modalities.


Leading real-time PCR technology

With more than 25 years of qPCR innovation, Thermo Fisher is a recognized leader in qPCR instrumentation. Applied Biosystems qPCR systems help deliver true value with excellent performance, reliability, and world-class support.

 

The MycoSEQ Mycoplasma Detection Assays have been functionally validated on the Applied Biosystems QuantStudio 5 Real-Time PCR System. A high-performance benchtop instrument, the QuantStudio 5 System gives you greater control of your experimental data. Interact with the latest advancements in touchscreen usability, access your data more easily than ever before, and built-in SAE to help enable 21 CFR Part 11 compliance.


Streamlined data interpretation for fast and accurate results

Applied Biosystems AccuSEQ Real-Time PCR Software offers efficient and streamlined data interpretation for analyzing contaminants and impurities in various testing scenarios. Serving as a pivotal element within an all-encompassing Mycoplasma detection solution, AccuSEQ software equips you with actionable results crucial for biopharmaceutical manufacturing processes.


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Analytics Knowledge Hub


Explore the Analytics Knowledge Hub from Thermo Fisher Scientific, providing a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize the use of our products in your bioprocess workflow.
 


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