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Mycoplasma Testing

Mycoplasma colonies

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.


 
  Mycosafe’s Quality Standards

  • Mycosafe is in compliance with GMP standards
  • Mycosafe is regularly inspected by the authorities and its clients

 
 
 
 
Mycosafe Diagnostics GmbH • BioTech Center Muthgasse, Muthgasse 11/2 • A-1190 Vienna, Austria •
T: +43-1-8907294 • F: +43-1-8907294-301 • E-Mail: office@mycosafe.atDisclaimer