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Mycoplasma Testing

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Mycoplasma TestingMycoplasma contamination events can lead to altered physio-chemical properties of cells, potentially resulting in reduced or altered cellular products and perhaps unsafe biopharmaceuticals. Thus, testing for the presence of mycoplasma contamination in development and manufacturing is a requirement by worldwide regulatory agencies. Guidance for this testing is provided in the United States Pharmacopeia (USP) Chapter <63> Mycoplasma Tests, European Pharmacopoeia (EP) Chapter 2.6.7 Mycoplasmas, Japanese Pharmacopoeia, Chinese Pharmacopoeia, and FDA 1993 Points to Consider (PTC).

Traditional compendial testing for mycoplasma includes direct culture and indicator cell culture methods. While both of these methods are the gold standard for mycoplasma detection, the timing for results is not conducive for newer autologous cellular therapies. To overcome this, Nucleic Acid Techniques, such as MycoSEQ™ and BioFire® are becoming more accepted.

Eurofins BioPharma Product Testing offers harmonizedmycoplasma assays, which comply with regulatory guidelines, as well as a fully validated 21 CFR 610.30 method.

Why Choose Eurofins BioPharma Product Testing?

  • We provide fully characterized and qualified positive control strains.
  • We have a formalized analyst training program, including required proficiency assessments using blind samples.
  • We perform mycoplasmastasis testing to qualify each assay for each test article.
  • With over 20 years of experience, we offer support for mycoplasma clearance studies, including consultation and study design.
  • We utilize an optimized proprietary media.

Mycoplasma Assays

Eurofins BioPharma Product Testing network of laboratories offers comprehensive mycoplasma services that are available for:

  • Testing of master, working and end-of-production cell banks
  • Unprocessed bulk harvest
  • Cell culture raw materials (e.g., serum, trypsin)
  • Final product release
  • ATMPS

Available Assays

  • Compendial
  • MycoSEQ™
  • BioFire

BioFire® Assay

The BioFire® assay encompasses the nucleic acid extraction, PCR plating and analysis within a single cartridge. This reduction in steps also provides a decrease in the timing of the test from start to finish. This system also targets RNA, of which the half-life is much shorter than that of DNA. By targeting RNA, only viable mycoplasma will be detected, reducing the possibility of false positive results. This assay meets EP 2.6.7 guidelines, as well as USP <63> and JP general chapter. With the advent of autologous cellular therapies, testing time is valuable. With the BioFire system, mycoplasma results may be obtained within three calendar days. For some extremely tight timelines, 24-hour results can be achieved.

Facilities & Instrumentation

  • Limited-access laboratories that are pressure-controlled, HEPA-filtered and operate on independent air handling systems to prevent cross-contamination.
  • Separate areas for testing of client test articles and handling of positive control strains, including a unidirectional workflow that ensures handling of test articles prior to manipulating positive controls on each working day.
  • Validated cleaning disinfection and environmental monitoring programs.
  • Access to our proprietary LabAccess.com system, allowing 24/7 easy access to study information, final reports and actual raw study data.
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