Cells utilized in the manufacturing of biological products must be shown to be free of adventitious agents including Mycoplasma. The US FDA advises in “Points to Consider on the Characterization of Cell Lines Used to Produce Biologicals,” that the potential contamination of Mycoplasma should be assessed utilizing indicator DNA fluorochrome staining and culture testing methods. Mycoplasma is one of the most common contaminants of cell lines and has the potential to affect cell growth in culture and reduce yields of biomolecules.
Mycoplasma Testing with Texcell
Texcell has developed a protocol capable of detecting a broad range of Mycoplasma species encountered in cell lines of human and animal origins. Our standard tests are validated and meet global regulatory requirements.
Available Mycoplasma assays include:
- Detection of culturable and nonculturable Mycoplasma (28 days)
- Detection of Mycoplasma by qPCR (>90 species)