Mycoplasmal Contamination: Risk Reduction Strategies and Diagnostic Methods
Mycoplasmal Contamination: Risk Reduction Strategies and Diagnostic Methods. J.A. Mariano. Bionique Testing Laboratories, 156 Fay Brook Drive, Saranac Lake, NY 12983.
Mycoplasma is considered to be one of the most prevalent and serious microbial cell culture contaminants in both research and industrial cell culture facilities. Reported rates of contamination have been in the range of 11-35% within established cell lines. Chronically infected cultures often occur with mycoplasmal contamination, since it often evades macroscopic and microscopic detection despite reaching concentrations of 107-108 cfu/mL in cell lines. Today, we have gained enormous recognition of the impact of contamination on the host cell. The potential sequelae of infection include chromosomal alterations and aberrations in every aspect of cellular metabolism. Consequently, the verification of mycoplasma-free cell lines is essential in the forward process decision-making steps within research and biopharmaceutical manufacturing. Current FDA approved testing methods require a minimum of 28 days to complete. However, significant progress has been made in the development and validation of rapid microbiological methods for the detection of mycoplasma. The potential impact of these new analytical methods in the testing of cell lines and cell-derived products will be reviewed in this presentation. Additionally, strategies to reduce the risk of contamination and transmission of infection to uninfected cell lines by applying stringent quality control measures will be discussed. In summary, the consequences of failing to establish a robust mycoplasmal testing program in any cell culture laboratory can result in the compromise of research endeavors, financial losses and more importantly, pose potential biosafety concerns in those facilities involved with preclinical safety testing or biopharmaceutical manufacturing.
Presented at the Annual Society for In Vitro Biology Meeting, June 6-10, 2009 in Charleston, SC.