Mycosafe offers a broad spectrum of QC mycoplasma testing services, including GMP-compliant testing methods according to regulatory standards specified by the European Pharmacopoeia (PhEur) and the US Food and Drug Administration (FDA), as well as less stringent DNA-amplification methods (polymerase chain reaction, PCR). The PhEur- and FDA-specified testing procedures apply to all biologicals and biopharmaceuticals produced in cell substrates and include a DNA staining procedure using indicator cell cultures to detect “non-cultivable” mycoplasmas, in addition to broth and agar culture procedures. Mycosafe also offers its expertise in mycoplasma species identification and strain characterisation using molecular techniques. |