METHOD FEASIBILITY
Bionique’s Hybrid Real-Time PCR Method Suitability service (M-1550) for method feasibility provides an evaluation of product specific suitability through the recovery of multiple species of mycoplasma from one lot of representative test article.
This service provides preliminary sensitivity and specificity data to determine product specific method feasibility.
Results are generated < 3 weeks from initiation.
Total Testing Time:
< 3 weeks
Sample Requirements:
Minimum Test Volume = 6.0 mL
METHOD Qualification
Hybrid Real-Time PCR Phase Appropriate Suitability (M-1550) for Method Qualification
This service provides a product specific qualification of the M-1500 as an alternate method. In addition to addressing sensitivity and specificity, this qualification also evaluates reproducibility in terms of both repeatability and ruggedness.
Results are generated < 12 weeks from initiation.
Total Testing Time:
< 12 weeks
Sample Requirements:
Minimum Test Volume = 24.0 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, risk-appropriate validation and CMC consultancy to support a rapid mycoplasma test method for lot release.
When should I use it?
Our various levels of product suitability service support a flexible and risk-based approach to demonstrating the appropriateness of this method for detecting mycoplasma in your product matrix and class.
Consider these services if your product release strategy would benefit from the low test article volume requirements, faster turnaround times, and enhanced sensitivity of our M-1500 Hybrid Real-Time PCR Testing listed below.
Our Hybrid RT-PCR assay supports rapid results where they are needed most including clinical products, cell banks, and raw material(s).
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.