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Mycoplasma Testing Service


As a leader of testing service, Creative Biogene offers a broad and extensive mycoplasma testing service under cGMP...

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Mycoplasma Testing Service

Mycoplasma Testing Service

As a leader of testing service, Creative Biogene offers a broad and extensive mycoplasma testing service under cGMP and the guidelines of UP, USP and JP. We have excellent scientists with years of experiences in mycoplasma testing. Our scientist team will provide reliable, rapid and accurate mycoplasma testing service to satisfy various needs of clients. Custom mycoplasma testing service is also available.

Mycoplasma are the smallest and simplest bacterial cells discovered and they show tolerance to many antibiotics due to lack of cell walls. Mycoplasma are pathogenic and may cause the infections in pediatric, geriatric, or immunocompromised patients. Mycoplasma contamination is a common problem in culturing cells and other biological materials produced in cells.

Since it is not typically visible with a standard microscope, mycoplasma contamination is difficult to detect and always may be underestimated. Therefore, mycoplasma contamination of biologics and pharmaceutics represents a potential safety risk for users. To minimize this risk, mycoplasma testing is an essential quality control requirement of pharmaceutics, biopharmaceutics and clinic products.

Creative Biogene employs various assays for mycoplasma testing, including direct culture method, indirect cell culture assay, PCR and qPCR assay. According to the guidelines of USP, EP and PTC, the direct culture method and indirect cell culture assay are the recommend ways to test different species of mycoplasma. PCR and QPCR assays, which are faster and simpler to detect the mycoplasma contamination, are recently accepted for application to biologics manufacture. All of the methods are available to meet all your needs. Creative Biogene offers state-of-the-art technology to provide an effective and efficient mycoplasma testing service for clients.

Mycoplasma Testing Service Figure 1 Various assays for mycoplasma testing.

Creative Biogene offers extensive mycoplasma testing services that are available for:

  1. Master Cell Bank and Working Cell Bank
  2. Raw Materials
  3. Unprocessed Bulk Harvest
  4. Final Product Release

For any more information, please feel free to contact us at or 1-631-626-9181.

Reference:

  1. Razin S. Mycoplasmas. In: Baron S, editor. Medical Microbiology. 4th edition. Galveston (TX): University of Texas Medical Branch at Galveston; 1996. Chapter 37.

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