Mycoplasma Detection Assays

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Rapidly detect Mycoplasma with confidence

Applied Biosystems MycoSEQ Mycoplasma Detection Assays help deliver highly accurate and sensitive results that meet or exceed regulatory guidance for Mycoplasma detection while facilitating 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 helps deliver 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

MycoSEQ kits include:

PrepSEQ Sample prep
 

Optional

TaqMan or SYBR Green Assay
 

 

TaqMan or SYBR Green Master Mix
 

 

Discriminatory Positive Control
 

 

Negative
control
 

 

DNA dilution buffer
 

 

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 trusted TaqMan chemistry. Developed specifically for the detection of Mycoplasma in cell therapy and complex bioproduction samples, TaqMan-based assays help deliver performance that meets or exceeds the regulatory requirements of 10 CFU/mL, the high level of performance needed to facilitate product lot release testing, including the ability to help 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 reaction 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 supports 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 limited 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 GC/mL, as recommended by regulatory guidance.

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+

On-demand webinars

On-demand webinar: Detecting contaminants, ensuring safety – high-performance Mycoplasma testing solution

On-demand webinar: A journey to Cell Therapy manufacturing—from R&D to lot-release

Analytics Knowledge Hub


Explore the Analytics Knowledge Hub and discover a robust collection of webinars, articles, eBooks, infographics, and other digital resources to help you optimize analytical testing in your bioprocess workflow.
 

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For Research Use Only. Not for use in diagnostic procedures.