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The Role of USP Mycoplasma Testing
In this article, we will discuss an overview of USP Mycoplasma Testing.
Mycoplasma are commensal parasites that can contaminate cell cultures as well as animal-derived products. They are not visible while doing the culture of cells like other contaminants. Mycoplasma contamination in a cell culture causes changes in protein synthesis and cellular metabolism including cellular morphology.
In some conditions, mycoplasma is pathogenic to humans. Like for instance, M.Pneumoniae infection in your respiratory tract, called walking pneumonia is persistent and is difficult to cure using conventional antibiotics. Because of all these concerns, when mycoplasma contamination is found in any biopharmaceutical product, there is a necessity for an instant and pivotal response like USP mycoplasma testing.
Response to mycoplasma contamination includes discarding all affected batches or putting a stop to production for cleaning and sanitization. Moreover, the raw materials like the cell cultures, biological media, components and serums used in the whole process should be tested and certified as clear of contamination.
Mycoplasma testing within these products is difficult to perform. Conventional testing for mycoplasma contamination is done according to compendia through two methods called direct culture method and indicator cell culture method. Both of these methods are reliable and well-organized but have some limitations.
Both of these methods need the sample matrix to not interfere with mycoplasma growth at the time of the process of that method. This is one main limitation in cases of some animal sera, sample matrices and viral vaccines that are out of the physiological PH range that offers support to the growth of mycoplasma.
What is USP 63 Mycoplasma testing?
USP mycoplasma testing is the procedure that United States Pharmacopeia has outlined for detecting and identifying mycoplasma contamination in cell cultures, biopharmaceutical products and raw materials.
USP mycoplasma testing includes using sensitive assays made for detecting mycoplasma presence that are commonly found in biological products. The testing methods mainly include PCR, Culture-based methodologies and other molecular methods.
The main objectives of USP 63 Mycoplasma testing are
- Certify the safety and eminence of the biopharmaceutical products by recognizing and removing mycoplasma contamination.
- Compliance with the regulatory needs set forth by the agencies like FDA and EMA.
- Executing standardized testing methods for attaining consistent and best results across various labs and manufacturing facilities.
- Prohibiting the mycoplasma transmission to the patient or the biopharmaceutical products end user.
USP nf Pharmacopeia mycoplasma testing offers the guidelines, and reference materials along with the validation protocols for supporting the execution of mycoplasma testing.
In USP 63 Mycoplasma testing chapter there are two methods for detecting mycoplasma. The first one is the agar and broth media process and the second one is the indicator cell culture process.
The mycoplasma species that are suitable for using the USP 63 Mycoplasma testing chapter are
- Acholeplasma Laidlawii – Vaccines, cell-derived materials, and cultures for use by humans and veterinary when any antibiotic is used at the time of production.
- M.gallisepticum – When avian material is used at the time of production or when a vaccine or cell culture is used in poultry.
- M.hyorhinis – For non-avian or veterinary vaccines or cell cultures
- M.orale – For vaccines for use in humans and veterinary
- M.Pneumoniae- Vaccine or cell banks for use of human or other suitable species of D-glucose fermenter like M.fermentas
- M.Synoviae – When avian material is used at the time of production or when vaccine or the cell bank is used in poultry.
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