Rapid Mycoplasma Testing
Mycoplasma contamination of cell lines used to produce biopharmaceutical products can disrupt cellular growth and metabolism and lead to changes in gene expression, which results in decreased product quantity and quality. For these reasons, worldwide regulatory agencies require that biotechnological products produced in cell substrates be tested to ensure the absence of mycoplasma contamination.
The challenge with mycoplasma testing is that current procedures are time consuming, requiring a 28- day duration. However, this time requirement is not amenable for obtaining the rapid lot release testing results needed for biopharmaceutical products that have short half-lives or those that are in high market demand. The lengthy assay period is also not conducive to the rapid screening of raw materials intended for use in future production, nor to the rapid in-process screening of intermediates for the purpose of detecting and containing contamination events.
Eurofins now offers a rapid mycoplasma test comparable in sensitivity to the 28- day compendial method.
To execute this rapid technology, Eurofins uses EMD Millipore’s MilliPROBE® Real Time Detection System for Mycoplasma. This system has the capability of processing a volume of material comparable to that tested in the compendial method, making it preferable to rapid mycoplasma detection methods that have volume limitations. The system incorporates features that allow it to preferentially detect viable mycoplasmas.
- Products with short half-lives (i.e., cell therapies)
- Unprocess Bulk Cell Culture Harvest
- Cell Banks
- Raw Materials
- Process Evaluation/Clearance Studies
Why Choose Eurofins?
- Our scientists have successfully demonstrated the value of this rapid technology without observing matrix interference effects.
- We can support all mycoplasma needs, including USP, EP, Points to Consider and harmonized methodologies.
- We offer GMP and non-GMP Assays.
Advantages of Using our Validated Assay
- Ensures rapid, robust and reliable culture-free mycoplasma detection.
- Delivers same-day preliminary results.
- Is less prone to matrix interference than other rapid methods.
- Achieves sensitivity comparable to culture-based compendial testing.
- Meets European Pharmacopeia 2.6.7 guidelines.