1. Home
  2. >
  3. Applications & Technologies
  4. >
  5. Biotherapeutics & Vaccine Production
  6. >
  7. Pharmaceutical Analytics
  8. >
  9. Mycoplasma Detection

Mycoplasma Detection

Dissociation Curves Chart

Dissociation Curves Indicating Positive
Results for the Presence of Mycoplasma

MycoSEQ® Mycoplasma Detection System

MycoSEQ® Mycoplasma Detection System

MycoSEQ® Mycoplasma Detection System


Mycoplasmas are potential contaminants in mammalian cell culture manufacturing. To ensure product quality, regulatory agencies recommend that all products produced in cell culture be tested for the presence of Mycoplasma. 

However, detecting these contaminants is difficult, sometimes impossible, when using traditional microbiological techniques. The current Mycoplasma test is a 28-day culture test. In 2007, the European Pharmacopeia accepted nucleic acid tests, such as real-time PCR, as an alternative method for traditional Mycoplasma detection after validation.

Detect Mycoplasma in Hours, Not Days. It's About Time.
The MycoSEQ® Mycoplasma Detection System integrates real-time PCR assays, instruments, and software with optimized PrepSEQ™ sample preparation reagents—delivering results in hours, not days. This enables you to test at multiple points in cell lines, cell banks, and harvest media, increasing your productivity and reducing risk of downstream contamination.
  • Detection of more than 90 Mycoplasma species
  • Demonstrated sensitivity to less than 10 copies/reaction
  • Proven specificity
  • Proprietary optimized sample preparation for high DNA recovery
  • Externally validated  to demonstrate sensitivity of a PCR based test for Mycoplasma that is not biased towards the success of PCR
  • Seamless integration from detection to identification using the MycoSEQ® Full Gene 16S rDNA Bacterial Identification Kit
The MycoSEQ® Mycoplasma Detection System’s easy workflow delivers actionable results in less than 4 hours—enabling you to detect contamination as early as possible in process development, equipment, raw materials, and finished product.

Workflow: Find the Products You Need for Every Step

Click the arrows above to view products