Mycoplasmas, the smallest known free living organisms, are relatively common bacterial contaminants of mammalian cell cultures. Regulatory guidance requires that all products derived from mammalian cell culture be tested for the presence of Mycoplasma.
Setting Up a Rapid Mycoplasma Assay Supporting Recombinant Production
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Regulatory guidelines state that recombinant bulk harvest needs to be tested for mycoplasma prior to further processing. This presentation will give an overview of Octapharma’s journey on replacing an out-sourced mycoplasma test with Thermo Fisher’s MycoSEQ qPCR assay. |
MycoSEQ mycoplasma detection system
Dissociation Curves Indicating Positive Results for the Presence of Mycoplasma
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Mycoplasma detection 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.
MycoSEQ® Mycoplasma Detection System
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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. 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. |
- 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 toward the success of PCR
- Seamless integration from detection to identification using the MicroSEQ Microbial Identification System.
The MycoSEQ Mycoplasma Detection System’s easy workflow delivers actionable results typically in less than 4 hours—enabling you to detect contamination as early as possible in process development, equipment, raw materials, and finished product.
Step-by-step guide to mycoplasma detection products
Purify DNA from your sample using the PrepSEQ® Mycoplasma Sample Preparation Kit easy magnetic bead-based protocol. Your sample can vary anywhere from 100µl to 10 ml of cell culture. The DNA you purify in this step will be used as your template for Real-Time PCR.
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Next, combine the purified DNA template with the assay mix and Power SYBR® Green Master Mix included in the MycoSEQ Mycoplasma Detection System.
Learn more:
Next, run your reaction mixture on a Real-Time PCR instrument.
AccuSEQ Real-Time PCR Software is an intuitive easy-to-use analysis tool for data interpretation. The software guides the user through the experiment and plate setup and provides easy-to-use tools for defining and setting up standards, controls, and unknowns. AccuSEQ v2.0 software is designed for analysis of results obtained from ViralSEQ, MycoSEQ, resDNASEQ, and ProteinSEQ kits.
Products
Purify DNA from your sample using the PrepSEQ® Mycoplasma Sample Preparation Kit easy magnetic bead-based protocol. Your sample can vary anywhere from 100µl to 10 ml of cell culture. The DNA you purify in this step will be used as your template for Real-Time PCR.
Learn more:
Next, combine the purified DNA template with the assay mix and Power SYBR® Green Master Mix included in the MycoSEQ Mycoplasma Detection System.
Learn more:
Next, run your reaction mixture on a Real-Time PCR instrument.
AccuSEQ Real-Time PCR Software is an intuitive easy-to-use analysis tool for data interpretation. The software guides the user through the experiment and plate setup and provides easy-to-use tools for defining and setting up standards, controls, and unknowns. AccuSEQ v2.0 software is designed for analysis of results obtained from ViralSEQ, MycoSEQ, resDNASEQ, and ProteinSEQ kits.
Products
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