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Mycoplasma Detection Testing
Rapid mycoplasma testing for lot-release and in-process testing
Mycoplasmas—the smallest known free-living organisms—are difficult-to-detect bacterial contaminants in mammalian cell cultures. In therapeutic applications, an undetected mycoplasma contamination can negatively impact product quality and patient safety. Manufacturers following cGMP guidelines develop stringent risk mitigation plans to ensure early detection of mycoplasmas to avoid costly manufacturing delay or remediation activities. For lot-release testing, regulatory guidance requires that all products derived from mammalian cell culture be tested for the presence of mycoplasma.
MycoSEQ Mycoplasma Detection System
The Applied Biosystems 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 Mycoplasma Detection System workflow provides a flexible approach to meet a variety of mycoplasma testing applications.
- 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 by our regulatory and field application specialists.
MycoSEQ Mycoplasma Detection Assays
Core to the MycoSEQ System are the real-time PCR assay kits. MycoSEQ mycoplasma detection assays deliver high sensitivity that meet or exceed regulatory guidance for mycoplasma detection while delivering same-day actionable results to enable early detection of mycoplasma contamination.
- Proven—Regulatory-accepted method for mycoplasma detection, with Drug Master File (DMF)*, filed with the United States Food and Drug Administration (FDA) and Health Canada
- Sensitive—Meets or exceeds the recommended regulatory guidance of 10 CFU/mL or 10 genome copies (GC)/mL for a wide variety of mycoplasma species, including those commonly known to contaminate bioprocessing cultures
- Specific—Validated in numerous independent studies* to specifically detect a wide variety of Mycoplasma, Acholeplasma, and Spiroplasma species with no known cross-reactivity with closely related bacterial species
- Fast—qPCR-based workflow delivers actionable results in less than 5 hours, enabling quick detection
of in-process, raw materials, or harvest contamination—helping expedite the release of
your product - Accurate—Discriminatory positive control allows discrimination between true mycoplasma and accidental contamination of test sample with positive control
*MycoSEQ Detection Assay
Proven, regulatory-accepted method for mycoplasma detection
The MycoSEQ Mycoplasma Detection System has been accepted world-wide to meet existing regulatory guidelines for the detection of mycoplasmas across multiple therapeutic modalities.
Let us help you implement and validate your mycoplasma testing >
eBook: Rapid Mycoplasma Testing Method for Lot-Release
Learn how the MycoSEQ Drug Master File with the US FDA and Health Canada can assist in regulatory acceptance of the method.
Simple qPCR workflow
Webinar spotlight:
Bringing Rapid Mycoplasma Testing In-House to Expedite Lot Release of Recombinant Protein Product
Share one customer’s journey to replace an out-sourced mycoplasma test with an in-house mycoplasma qPCR assay. Octapharma received regulatory approval for the assay in October 2019 and now uses in-house mycoplasma testing for lot release, saving lead time for their recombinant production.
Request a technical consultation
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 MycoSEQ solution and products. Complete this form to start the conversation.
Educational resources
Take advantage of educational webinars from industry thought leaders
| Making the Switch: The Evaluation, Implementation, and Validation of Bringing Rapid Mycoplasma Testing In-House to Expedite Lot Release of Recombinant Protein Product This presentation provides an overview of Octapharma’s journey on replacing an outsourced mycoplasma test with an in-house mycoplasma qPCR assay. Octapharma received regulatory approval for the assay in October 2019 and plan to run in-house mycoplasma testing for lot release, saving lead time for their recombinant production. |
| A Journey to Cell Therapy Manufacturing: From R&D to Lot-release Learn three key areas to consider when commercializing a cell therapy—starting/raw materials, controlled manufacturing processes, and testing safety and quality. We highlight things to watch for and review essential tests required for lot release and regulatory filing and present solutions that save time and are accepted by regulators for lot release testing. |
| Accelerating Vaccine Development by Innovative PurificationSolutions and State of the ArtQuality Testing This webinar addresses regulatory requirements for safety and purity testing during the vaccine production process and highlights the benefits of implementing automated systems to save time and demonstrate product quality and safety. |
| Scalable AAV manufacturing–Addressing challenges across the workflow In this webinar, upstream and downstream solutions across the AAV production workflow are outlined. It also covers regulatory requirements for safety and purity testing during the AAV production process and discusses the benefits of implementing automated systems. |
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