New Assay for Rapid Detection of Mycoplasma Contamination Introduced
August 27, 2009 – Mycoplasma contamination is a common problem for cell cultures and can lead to compromised safety in a final product. The risks of mycoplasma contamination are compounded by how difficult and time-consuming it can be to detect. To address these issues, we now offer a mycoplasma assay that is highly sensitive, takes half the time of traditional cell culture methods and has been validated according to European Pharmacopoeia guidelines.
Mycoplasmas are parasitic organisms found both externally and intracelluarly on eukaryotic host cells. These small organisms have no rigid cell wall, making them resistant to some antibiotics and able to pass through normal filters. They can originate and be introduced into a cell culture through a wide range of avenues, including laboratory personnel and contaminated animal sera and aerosols.
Testing is advised and, in many cases, regulated throughout the world for contamination in master cell banks, working cell banks, virus seed lots, control cells, virus harvests, bulk vaccines, final batch lots, monoclonal antibodies, immunological modulators, interferon and other cytokines, growth factors and any biological materials produced in cell substrates.
With our new mycoplasma assay, we provide broad-ranging, trustworthy and highly sensitive (10 CFU/mL) results in just 14 days. The assays are performed using nucleic acid amplification techniques (NAT) and fluorescent probe technology, which increases specificity and allows real-time detection of amplification signals. In addition, the assay includes nucleic acid spike controls to assess potential amplification inhibition by the sample.
For more information about this new assay, or any of our other biopharmaceutical services, contact us at 1.877.CRIVER.1. (1.877.274.8371) or askcharlesriver@crl.com.
Related Information: