Rapidly detect Mycoplasma with confidence
Applied Biosystems MycoSEQ Mycoplasma Detection Kits offer a fully integrated solution for real-time PCR–based Mycoplasma detection. Used throughout the bioproduction workflow, MycoSEQ kits are an alternative to costly, time-consuming culture-based tests, delivering accurate and actionable results in about five hours. Backed by technical and regulatory experts and a successful track-record of regulatory acceptance, MycoSEQ Detection Kits can help simplify mycoplasma detection for both in-process and lot-release testing.
MycoSEQ Detection Assay Kits offer a variety of solutions to meet sample and workflow requirements:
- Chemistry options include probe-based or dye-based qPCR assays to ensure optimum performance, regardless of sample matrices
- Kits available with and without sample preparation supporting both manual and automated extraction
Featured solution: MycoSEQ Plus Mycoplasma Detection Kit
The Applied Biosystems MycoSEQ Plus Mycoplasma Detection Kit is a probe-based quantitative PCR (qPCR) assay kit featuring gold-standard TaqMan chemistry. Developed specifically for the detection of Mycoplasma in cell therapy and complex bioproduction samples, TaqMan-based assays deliver performance that meets or exceeds the regulatory requirements of 10 CFU/mL, the high level of performance needed to support product lot release testing, including the ability to meet regulatory guidance for assay sensitivity and specificity.
- Multiplexed assay enables simultaneous screening of over 200 species of Mycoplasma, with no demonstrated cross-reactivity to closely related bacterial species
- Demonstrated to meet or exceed LOD less than/equal to 10 GC/mL for all mycoplasma species listed in Pharmacopoeia (USP, EP, JP), as well as representative hemoplasma, mesoplasma and ureaplasma.
- Unique discriminatory positive control that can differentiate a control-based contamination event from a true positive sample call
- Flexible and scalable throughput supports fluctuating testing needs and enables reduced cost per rxn by batch testing multiple samples
- Limits risk to production facilities as it does not require live Mycoplasma for testing or process validation.
- Internal positive control confirms PCR reaction consistency across all samples
MycoSEQ Mycoplasma Detection Kit
The tried and true Applied Biosystems MycoSEQ Mycoplasma Detection Kit set the standard for rapid Mycoplasma testing and has been validated in more than 44 therapeutics across a variety of modalities. This dye-based assay design utilizes a proprietary bioinformatics pipeline to detect >90 Mycoplasma species with high specificity and no cross-reactivity with closely related bacterial species. Its sensitivity has been demonstrated by internal and external validation methods to detect 10 CFU/mL, or the genomic equivalent of 10 10 cfu/mL, or the genomic equivalent of 10 GC/mL, as recommended by regulatory guidance
Download the MycoSEQ Mycoplasma Detection Kit product bulletin ›
Application spotlight
Mycoplasma testing in monoclonal antibody production
bioreactor growth and bulk harvest lot release.
Learn about implementing the MycoSEQ Plus mycoplasma detection system throughout various stages of a CHO cell–based bioproduction process in this application note.
Compare MycoSEQ Assays
| MycoSEQ Plus Kit | MycoSEQ Kit |
Sample type | Bioproduction media, cells | Bioproduction media, cells |
Therapeutic type | Cell therapies, gene therapies, viral vector based therapies, biosimilars | Cell therapies, gene therapies, viral vector based therapies, biosimilars |
Detection chemistry | TaqMan (probe based) | SYBR (dye based) |
Number of reactions per kit | 100 | 100 |
Hours per workflow | ≤ 5 hours | ≤ 5 hours |
Discriminatory positive control | Yes | Yes |
Internal positive control | Yes | No |
Performance capable of meeting lot release requirements | Yes | Yes |
Number of species | 200+ | 90+ |
Webinar spotlight:
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.
The sample sets the stage
Efficient sample preparation and DNA extraction are the basis for a high-sensitivity assay. Our Applied Biosystems PrepSEQ nucleic acid extraction kits utilize magnetic bead-based technology to provide quantitative recovery of nucleic acids from a variety of complex sample matrices. Our MycoSEQ system is optimized with sample preparation protocols for use with either automated or manual workflows.
PrepSEQ kits are available separately or can be bundled with either MycoSEQ or MycoSEQ Plus kits for a complete workflow and added savings.
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