Cells used to manufacture of biological products must be shown to be free of adventitious agents including mycoplasma.
Mycoplasma Testing with Texcell include
- Detection of culturable and non-culturable mycoplasma
- Detection of mycoplasma by qPCR (>90 species)
Texcell has developed several protocols to detect 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 (ICH Q5D, 1993 PCT, EP 2.6.7)