Help ensure the safety of your biotherapeutic with rapid Mycoplasma detection
The Applied Biosystems™ MycoSEQ™ Plus Mycoplasma Detection Kit is a probe-based quantitative PCR (qPCR) assay kit featuring gold-standard TaqMan™ chemistry. Developed for the detection of Mycoplasma in cell therapy and complex bioproduction samples, MycoSEQ Plus assays deliver results that meet or exceed the regulatory requirements of 10 CFU/mL, the high level of performance needed to support product lot-release testing.
- Multiplexed assay enables simultaneous screening of 200+ Mycoplasma species
- Does not require live Mycoplasma for testing or process validation
- Delivers actionable results in less than 5 hours
- Part of a total workflow solution from sample prep to analysis, including SAE compatible software
Discover the MycoSEQ Mycoplasma Detection System--an integrated, real-time PCR (qPCR) solution for rapid mycoplasma testing. Comprised of functionally confirmed sample-to-answer protocols, commercially available assay kits, and instruments with analytical software to help enable regulatory compliance, the MycoSEQ System provides a flexible approach for Mycoplasma testing applications.
Learn more about the latest addition to the MycoSEQ System—the MycoSEQ Plus Mycoplasma Detection Assay. This TaqMan-based assay offers high sensitivity that meets or exceeds regulatory guidance for Mycoplasma detection while providing same-day actionable results to enable early detection of Mycoplasma contamination.
The MycoSEQ Plus Mycoplasma Detection Assay delivers outstanding sensitivity, specificity and accuracy – all critical attributes for Mycoplasma detection testing. Download this product bulletin to see product specifications and performance data.
In this application note, the capability of the MycoSEQ Plus System to detect mycoplasmas was demonstrated using samples related to common testing points in a mAb production process. Test samples were taken during in-process, bioreactor growth and bulk harvest lot release from a CHO cell–based mAb production workflow.
Ensuring the safety and quality of ATMP or cell-based therapeutics is critical for their successful translation into clinical applications. Mycoplasma contamination poses a significant risk to the safety and overall integrity of cell therapies, necessitating robust and rapid detection methods. Join us as we discuss the benefits and performance characteristics of using a PCR-based rapid testing approach to mycoplasma detection.
This infographic explores the impact of mycoplasma contamination and the most accurate and sensitive way to detect it.
Regulators require that the cell culture-based bioprocesses used for manufacturing of protein therapeutics, vaccines, and cell and gene therapy products be tested to ensure they are mycoplasma free. Traditionally, testing was done using a culture-based, 28-day mycoplasma test. More recently, PCR-based alternatives have evolved, driven by an industry move to shorten lot disposition cycles and the emergence of cell-based therapeutics that require a more rapid test. Recent regulatory guidance allows manufacturers to select rapid tests – as long as they are validated to demonstrate sensitivity and specificity that are comparable to or that improve upon traditional tests. The big question: how should manufacturers respond?
