In the development of biologics and advanced therapies, the presence of mycoplasma can bring production to a standstill and have a long-lasting impact.

The resulting decontamination procedures are costly, and time-intensive. Therefore it’s essential to ensure that your product is free from mycoplasma, as these microorganisms can harm patients, causing illnesses such as bronchitis or pneumonia, and degrade product quality.

Mycoplasmas are very small free-living organisms similar to bacteria but lacking a cell wall. They are ubiquitous in nature and are potential contaminants in biotechnology and cell-based products. Biological products require examination for the presence/absence of mycoplasmas before release for sale/use. Since mycoplasmas have been commonly found to contaminate cell cultures, it is important to check these periodically to ensure they remain free from infection. This is especially important where these cells may be developed as master cell stock for product development purposes.   

Eurofins BioPharma Product Testing New Zealand delivers robust, harmonised mycoplasma assays that support compliance with global regulatory standards. Our solutions are designed to support safe, contamination-free, and efficient production. We offer a full suite of traditional, semi-rapid, and rapid mycoplasma testing services to suit both early-stage development and time-critical releases.

Principle of tests

Mycoplasma detection by conventional test

Two test methods are followed to detect mycoplasma contamination:

• Enrichment in broth and detection by colony formation on selective agar plates
• Enrichment in cell culture and characteristic fluorescent staining of DNA
  
  

Mycoplasma detection by PCR

Two test methods are available:

• PCR mycoplasma screening test
• Rapid PCR test as an alternative to conventional methods 

Sample requirements

Please contact us to discuss your project requirements.

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