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 BioPharma Product Testing now offers a rapid mycoplasma test comparable in sensitivity to the 28-day compendial method.
To execute this rapid technology, Eurofins BioPharma Product Testing uses ABI’s MycoSEQ Real Time Detection System for Mycoplasma. This SYBR Green based system, which utilizes magnetic beads to purify mycoplasma DNA, 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 over 90 different viable mycoplasma DNAs.
- 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 BioPharma Product Testing?
- 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 results with a full CoA release within 5 days.
- Achieves sensitivity comparable to culture-based compendial testing.
- Meets European Pharmacopeia 2.6.7 guidelines.
|Melt curves of Applied Biosystems’ discriminatory positive control (tan curve) and a CHO-S aliquot spiked with live mycoplasma (M. pneumoniae at ≤10 CFU/mL; green curves)||Amplification plots and melt curves of Applied Biosystems’ discriminatory positive control (tan curve) and a CHO-S aliquot spiked with live mycoplasma (M. pneumoniae at ≤10 CFU/mL; green curves). The discriminatory positive control has a Tm range of 82-86°C which is distinctly different then the Tm range for mycoplasma (76-81°C). The different profile allows for the differentiation between a true positive mycoplasma contamination and a potential false positive result.|
Species for which Eurofins BioPharma Product Testing performed a user verification of limit of detection:
- M. orale
- M. hyorhinis - α
- M. pneumoniae
- S. Melliferum
Species Detected by ABI MycoSEQ System
- A. laidlawii
- M. pneumoniae
- M. orale
- M. hyorhinis
- M. synoviae
- M. fermentans
- M. arginini
- S. citri
- M. salivarium
- M. hominis
Bold = EP listed strains
Note: As stated above, MycoSEQ can detect over 90 mycoplasma species according to the vendor. The species listed above were used in the original vendor validation.
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