Mycoplasma and spiroplasma 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 and spiroplasma 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 Pharmacopeia, FDA 1993 Points to Consider (PTC), and the Code of Federal Regulations 21 CFR 610.30 test for mycoplasma plasma and spiroplasma.
In 2012, the U.S. European, and Japanese 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. Harmonized spiroplasma testing as required by the U.S. and European methods was added in 2014. 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/JP/PTC assays.
Eurofins Lancaster Laboratories offers harmonized mycoplasma and spiroplasma assays, which comply with the USP <63> 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 Lancaster Laboratories?
- 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 Lancaster 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
Facilities & Instrumentation
- Limited-access laboratories that are pressure-controlled and HEPA-filtered to prevent cross-contamination.
- Separate laboratories 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 Eurofins Lancaster Labs’ proprietary LabAccess.com system, allowing 24/7 easy access to study information, final reports and actual raw study data.
Request more information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.