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.
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.
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.
*MycoSEQ Detection Assay
The MycoSEQ Mycoplasma Detection System has been accepted world-wide to meet existing regulatory guidelines for the detection of mycoplasmas across multiple therapeutic modalities.
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.
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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.
For Research Use Only. Not for use in diagnostic procedures.