Application of qPCR method for Mycoplasma detection

qPCR is a molecular biology technique in which a specific DNA sequence is amplified and simultaneously quantified.

In Procelltech qPCR is used to detect whether a sample, either a supernatant or a cell suspension, is contaminated with Mycoplasma or with adventitious viruses.

To detect Mycoplasma, the most commonly used and approved by the European Pharmacopeia method, is the Broth Culture Method that, after 14 days, allows to detect at least 10 CFU/ml of Mycoplasma in a cell culture supernatant.

Alternative methods such as qPCR can be used providing that acceptability criteria of the official method, such as Limit of detection, Sensitivity and Specificity are maintained.

In Procelltech, Mycoplasma contamination detection by qPCR will be used as quality control of Adult Stem cell cultures released in cGMP condition from cell factories.

In addition, in Procelltech, qPCR will be used for contamination detection by specific viruses (based on virus sequence) and retroviruses by quantitative PERT which is now recommended by authorities for quality control testing of biological production in cGMP.