Mycoplasma Detection

Testing for mycoplasma is required for biologicals produced for clinical investigation and as licensed biologicals including:

• Recombinant Proteins
• Monoclonal Antibodies
• Viral Vaccines  (live and inactivated)
• Novel Therapies

Mycoplasma contamination in a cell line may be difficult to detect and is not typically visible with a standard microscope and does not cause any changes to growth media even at high concentrations.

We offer regulatory-compliant methods to detect mycoplasma:

• Agar and semi-solid broth methods
• Detection of both cell dependent and cell associated mycoplasma
• Indicator cell lines
• Quantitative PCR 
• ELISA

Our mycoplasma detection assays are offered to cGMP, are validated to the current ICH guidelines, and meet or exceed the United States Pharmacopeia, European Pharmacopeia, Japanese Pharmacio.

Assays for detection of mycoplasma use optimal:

• Mycoplasma growth conditions
• Growth media
• Incubation conditions
• Sub-culture schedule
• Indicator cells for non-cultivable mycoplasma