Testing
Bionique’s validated, Hybrid Real-Time PCR assay (M-1500) incorporates a brief enrichment period using our proprietary mycoplasma culture medium followed by RT-PCR analysis.
This method offers the key advantages of enhanced sensitivity, neutralization of potential inhibitory matrix components, and the ability to differentiate between viable and nonviable contaminations, if necessary. This assay can be used to support a rapid lot release test after the successful completion of a phase-appropriate validation.
Bionique can further mitigate concerns you may have with matrix effect by conducting a Matrix Qualification for your sample.
Total Testing Time:
3-6 days
Sample Requirements:
Minimum Test Volume = 1.2 mL*
*Note: Submitting less than the required volume will impact the test sensitivity.
Tests will be initiated if sample volume is found to be insufficient at time of set-up.
| GMP Testing Service | Validated Test | Method Suitability Testing | |
|---|---|---|---|
| M-1500 | |||
| M-1500Q |
Qualification
Real-Time PCR Matrix Qualification (M-1500Q)
Any sample submitted for the Hybrid Real-Time PCR analysis should be qualified to evaluate interference, either from the growth of the organism or interference on the PCR, as well as demonstrate the suitability for its intended purpose. This analysis would only need to be conducted once for any given sample unless there are changes in the test article components or manufacturing process.
Total Testing Time:
3-6 days
Sample Requirements:
Minimum Test Volume = 1.2 mL*
Need to Rapidly Test
Advanced Therapies?
The unique nature of cell and gene therapy products, including limited production volume, limited shelf life, and other factors demand new approaches to mycoplasma testing.
Bionique has evolved the tools needed to address the unique product characteristics and requirements inclusive of rapid, reliable, and small volume testing assays. Bionique has developed a routine rapid, reliable and robust molecular method for testing of cell and gene therapy products with sensitivity comparable to the 28-day compendial methods.
In addition, Bionique offers custom assay development, phase-appropriate validation and CMC consultancy to support a rapid mycoplasma test method for lot release.
When should I use it?
Our Real-Time PCR assay (M-1500) is a rapid mycoplasma detection test that is ideal for use cases which require fast turnaround times, high testing sensitivity, or both.
Consider this assay if you require expert testing of the applications below, or if your clinical/commercial program would be enhanced from the unique benefits below:
RT-PCR Applications
Our RT-PCR assay is best suited to the following types of applications:
Lot Release |
|
Cell Banks |
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Cell & Gene Therapy |
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Raw Materials |
|
RT-PCR Benefits
Consider our RT-PCR assay if your program could benefit from the following:
Short Testing Times |
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High Sensitivity |
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Inhibitory Matrix Neutralization |
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Would you like to learn more?
To obtain more information about our services
or to speak to a team expert contact us now.