Arvind Manikantan Padma
The method is used to detect Mycoplasma contamination in biological samples, e.g., tissues, cells, gene therapies, cell therapy products, or tissue engineering products
Mycoplasma contamination is a widespread and recurring problem in in-vitro platforms in medical research and the pharmaceutical industry. Mycoplasma can grow in culture media without showing typical signs of bacterial contamination such as turbidity and does not affect cultured cells with altered metabolism, slower proliferation, and chromosomal abnormalities. This makes Mycoplasma testing and thus the maintenance of contamination-free in vitro systems fundamental to medical research and to the manufacture of goods in the pharmaceutical industry.
Mycoplasma is specifically detected by amplifying a highly conserved rRNA operon, or more specifically, a 16S rRNA coding region in the mycoplasma genome. Quantitative PCR (qPCR) is used to amplify this region. The method is validated according to European Pharmacopoeia 2.6.7 with different types of sample material.
Report with titer value
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Detection of mycoplasma by qPCR for ATMP products and cell cultures
Life Science, Pharmaceuticals, Medical devices
European Pharmacopoeia 2.6.7
Price on tender
According to the agreement
- Cells should be cultured in the absence of antibiotics for at least a week or two passages before submission to prevent false negative results.
- To maximize test sensitivity, cell cultures should be maintained in the same medium without dilution with fresh medium for three days prior to testing.
- Cryopreserved cell cultures should be cultured approximately two weeks prior to specimen submission to ensure detectable mycoplasma levels.
- The mycoplasma test should be performed at the end of the exponential phase (near confluence).
When ordering, a protocol is sent on how the sample should be sampled in the correct way.