Mycoplasma Detection Assays | Thermo Fisher Scientific

Mycoplasma contamination detection assays for lot-release testing

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

Components of the MycoSEQ Plus Mycoplasma contamination detection for lot-release testing

MycoSEQ Mycoplasma Detection Kit

Components of the MycoSEQ Mycoplasma contamination detection assay for lot-release testing

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.

Download 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:

Watch the featured webinar on Cell Therapy Manufacturing

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.

Watch now

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.

Learn more about PrepSEQ and our sample prep solutions ›

Ordering information

Sample preparation

MycoSEQ Assay kits

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