Application Note: Mycoplasma Test Highlights
- Mycoplasmas are thought to contaminate 15-80% of cell cultures in bioreactors worldwide
- MiQLab rapidly detected 100% of the tested mycoplasma samples within two hours, with no false positives
- MiQLab can provide rapid, at-line, detection for mycoplasma, aiding in validating product quality for biopharmaceutical manufactures
Introduction
In this Mycoplasma application study, we focus on the bioprocessing industry. Bioprocessing can be broadly defined as the utilization of living organisms or related components to manufacture products for several different industries.1 The bioprocessing workflow consists of three stages: upstream, harvest, and downstream.2 The upstream aspect involves cell line development and setting up culture conditions to maximize cellular growth. Once cells reach a high enough concentration, they are harvested so that biological product can be extracted, isolated, concentrated, and purified to make the final product.
Mycoplasmas (Figure 1) are thought to contaminate 15 to 80 percent of cell cultures worldwide.3 Common methods for mycoplasma detection are extremely slow, taking approximately 28 days for definitive results.4
Routine microbial contaminant testing during bioprocessing is imperative to maintain control over product yield, quality, safety, efficacy, and to correctly identify any microbial contamination (Figure 2).
Reducing the time to result of contaminant test is therefore crucial to allow companies to make swift and precise decisions affecting manufacturing process. There are significant financial implications for a mycoplasma contamination event, where examination and decontamination procedures, corrective actions, product shortages, and damages to the manufacturers
brand can lead to millions of dollars spent per incident.5
Mycoplasma species, specifically Mycoplasma arginini, Mycoplasma orale, Mycoplasma hyorhinis, and Mycoplasma fermentans, as well as a close relative Acholeplasma laidlawii, are all a major concern for microbial contamination in bioprocessing.6 A mycoplasma test was designed to detect all the abovementioned five species of mycoplasmas. LexaGene’s MiQLab was used to perform the tests. It is a fully automated, rapid, molecular diagnostic system which utilizes the power of real-time or quantitative Polymerase Chain Reaction (qPCR), considered the gold standard in the field, and known for its high sensitivity and specificity. Given its small footprint, the MiQLab could be implemented at the point-of-need, or in this case at-line, to greatly reduce time to results and reduce loss of product. To validate the ability to accurately detect mycoplasmas, we performed a molecular biology inclusivity/ exclusivity study.
Download the full application note – Rapid Detection of Mycoplasmas, a Common Bioreactor Contaminant, Using MiQLab Mycoplasma Test
