Mycoplasma 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 Mycoplasma Tests, European Pharmacopoeia (EP) Chapter 2.6.7 Mycoplasmas, FDA 1993 Points to Consider (PTC), and the Code of Federal Regulations 21 CFR 610.30 test for mycoplasma.
In October 2010, the U.S. and European mycoplasma methods were brought into alignment, enabling the creation of harmonized direct culture and indirect cell culture assays. A single assay of each type will now be able to meet or exceed regulatory requirements. Viral vaccines, however, require testing in accordance with 21 CFR 610.30. The 21 CFR 610.30 is a more extensive direct culture method with multiple incubation conditions and growth media requirements that can not be harmonized with the USP/EP/PTC assays.
Eurofins BioPharma Product Testing offers harmonized mycoplasma assays and detection, which comply with the USP monograph, FDA 1993, PTC, JP and the EP 2.6.7 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.
- We offer support for mycoplasma clearance studies, including consultation and study design.
Eurofins BioPharma Product Testing offers comprehensive mycoplasma services, performed by PCR and compendial methods, 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
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