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MycoSEQ Mycoplasma Detection Kits

Ensure regulatory compliance, protect your cells, and prevent contamination.

Applied Biosystems MycoSEQ Mycoplasma Detection Kits

Why Choose Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits?

Precise Detection

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits are designed to detect all recommended mycoplasma species listed in major pharmacopeias with high sensitivity and specificity. They can detect less than or equal to 10 genomic copies per milliliter (GC/mL), ensuring reliable detection without cross-reactivity to closely related bacterial species. 

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Rapid Results

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kits deliver accurate and actionable results in approx. 5 hours. This rapid turnaround time is significantly faster than traditional culture-based methods, which can take up to 28 days. This speed enhances the efficiency of bioproduction workflows by providing timely detection of mycoplasma contamination.

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Regulatory Compliance

Applied Biosystems™ MycoSEQ™  Mycoplasma Detection Kits are accepted worldwide as meeting existing regulatory guidelines for mycoplasma detection, including those from the EU, US, and JP pharmacopeias. They are also designed to support qualification guidelines from the International Conference on Harmonisation (ICH). This broad regulatory acceptance simplifies compliance processes across multiple therapeutic modalities.

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Applicable Solutions

Applied Biosystems MycoSEQ Mycoplasma Detection Kits

Product Safety in Cell Therapy Development

The presence of mycoplasma can significantly compromise the quality, safety, and efficacy of the final therapeutic product, as well as pose serious health risks to patients. Regulatory agencies thus mandate sensitive and specific mycoplasma testing methods to ensure compliance with safety and quality standards in cell therapy manufacturing.

Applied Biosystems™ MycoSEQ™ Plus Mycoplasma Detection Kit

A probe-based quantitative PCR assay utilizing TaqMan™ chemistry, designed to meet or exceed regulatory requirements and accurately detect over 200 mycoplasma species.

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit

Validated in over 42 therapeutics, this SYBR™ Green-based assay detects 90 mycoplasma species with high specificity and sensitivity.

Applied Biosystems™ PrepSEQ™ 1-2-3 Mycoplasma Nucleic Acid Extraction Kit

Optimized for MycoSEQ™ detection kits, efficiently extract and recover mycoplasma DNA from various sample types in under 2 hours.

Applied Biosystems™ AutoMate Express™ Nucleic Acid Extraction System

This easy-to-use benchtop instrument automates the nucleic acid extraction process for up to 13 samples using the MycoSEQ™ mycoplasma detection workflow.

Applied Biosystems MycoSEQ Mycoplasma Detection Kits

Related Documentation

Applied Biosystems™ MycoSEQ™ Assay Kits

Read about the benefits of using the Applied Biosystems™ MycoSEQ Assay Kits in this brochure.

Applied Biosystems MycoSEQ Mycoplasma Detection Kits

The Way Forward in Mycoplasma Detection

Features and benefits of the updated Applied Biosystems™ MycoSEQ™ Plus Assay Kits.

The Way Forward in Mycoplasma Detection

The Way Forward in Biotherapeutic Analytics

Rapid analytical solutions for environmental monitoring, critical materials testing, in-process testing, and lot-release quality control testing.

The Way Forward in Biotherapeutic Analytics

FAQ

Yes, MycoSEQ™ Mycoplasma Detection Kits are validated for use in therapeutic production and the MycoSEQ Mycoplasma Detection Kit is used in over 42 therapeutics. It meets or exceeds regulatory guidelines for sensitivity and specificity with a sensitivity of 10 CFU/mL or 10 GC/mL, making it a reliable choice for ensuring the safety and compliance of cell-based products. The kit's validation in various therapeutics demonstrates its effectiveness and reliability in detecting mycoplasma contamination in diverse applications.

Yes, MycoSEQ™ Mycoplasma Detection Kits accommodate a wide range sample volumes ranging from 100μL to 50mL.

No, live mycoplasma is not needed. MycoSEQ™ Mycoplasma Detection Kits do not contain any live mycoplasma and do not require use of live mycoplasma for validation.