Mycoplasma Detection Solutions

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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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No matter your questions, we are here to help. Our experienced team of scientists and technical specialists is ready to assist you in choosing the right solution and products. Complete this form to start the conversation.
 

 

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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