Mycoplasmas are one of the most prevalent and serious microbial contaminants encountered within the manufacturing of biopharmaceuticals. Contamination can occur at all stages, from the research to clinical development and production. Despite all the monitoring measures set up by companies, Mycoplasma contamination represents a significant economic and safety risk within the biopharmaceutical industry.
Mycoplasma contaminants may be introduced into cell culture and biological products through
- the master seeds
- the master cell seed (stock)
- starting materials of animal origin
- in processing of biological materials during passage and product assembly.
Contamination rates in established cell cultures have been reported between 15 and 35% with considerably higher occurrence (up to 80%) cited in certain selected populations. Mycoplasma contaminations can seriously impact the reliability and reproducibility of experimental results, representing a major problem for basic research as well as for the manufacturing of bioproducts.
Sources of contamination:
- Cross contamination from untested infected cells
- Contaminated materials and reagents
- Personnel & Equipment: poor culturing practices, dust and aerosol
Over 190 mycoplasma species are known, but only a small number are responsible for the 95% of cell culture contamination events: M.Gallisepticum, M.A.Laidlawii, M.Orale, M.Fermentans, M.Pneumoniae, M.Sinoviae.
Thanks to the wide experience of our specialists, Mérieux NutriSciences can provide strong strategies to detect the presence of Mycoplasmas through robust studies and biosafety analyses according to European Pharmacopoeia (7th Edition, 2011, 2.6.7) and USP <67> :
- MYCROBIOLOGICAL CULTURE - DIRECT ASSAY
- INDICATOR MAMMALIAN CELL CULTURE ASSAY - INDIRECT ASSAY
- PCR-based METHOD - GMP validated according to Eu Ph 2.6.7
All the mycoplasma assays developed by MXNS provide the use of different positive controls including M.Gallisepticum, M.A.Laidlawii, M.Orale, M.Fermentans, M.Pneumoniae, M.Hyorhinis, M.Sinoviae.
Mérieux NutriSciences can performed the detection of Mycoplasma contamination on:
- Cell Line - Cell Banks/Stocks and Cell Therapy products
- Viral Banks/Stocks, Viral Gene Therapya and Viral Vaccine Products
- End of Production Cells for Biopharmaceuticals
- Bulk Drug Substance and Final Drug Product for Protein Products