Mycoplasmas are common and may cause contamination in biopharmaceutical production. Thus mycoplasma test is an essential requirement for quality control in biopharmaceuticals. Biological products, as well as allied materials that used to generate these products, can be determined for safety during mycoplasma test. According to the United Stated According to the United States Pharmacopeia, two methods are generally required to detect mycoplasma contamination of biological products. They are the agar and broth media procedure and the indicator cell culture procedure.
Mycoplasma test is critical for biologicals produced for therapeutics including:
- Monoclonal antibodies
- Recombinant proteins
- Vaccines (live and inactivated)
Creative Proteomics offers a variety of mycoplasma tests service:
- Agar and broth media method (culture methods)
- Indicator cell culture method
- Quantitative PCR
- Nucleic acid amplification techniques (NAT)
- ELISA
Culture Method
Culture method is a direct assay that usually detected by colony formation on nutrient agar plates. The test articles are expanded in broth culture (liquid growth media) which is capable to growing various mycoplasmas including aerobic, microaerophilic and anaerobic strains. The test article is incubated in the liquid media before inoculated onto the agar plates. After the prescribed incubation days, the presence of mycoplasma colonies on the agar plates can be observed by microscopy. If suspect colonies are observed, suitable validated method should be used to determine whether they are due to Mycoplasmas.
Indicator Cell Culture Method
In the indicator cell culture method, cell cultures are stained with a fluorescent dye binding DNA. Mycoplasmas are detected by their characteristic particulate or characteristic fluorescent attaining of DNA on the cell surface. Sometimes the mitochondria in the cytoplasm may also be stained, but it can be distinguished from mycoplasmas. Visual observation is used to identify the contaminating mycoplasma by fluorescent microscopy. If the interpretation of results for viral suspensions is affected by significant cytopathic effects, a specific antiserum can be used to neutralize the virus. The specific antiserum should have no inhibitory effects on Mycoplasmas.
Creative Proteomics provides a variety of methods for mycoplasma contamination. Scientists from Creative Proteomics are professional and they can help you detect mycoplasma of test article and support for mycoplasma clearance studies.
