16s Ribosomal Rna Gene Sequencing: Establishment of a Method for the Identification of Microorganisms in Biopharmaceutical Production Areas

In biopharmaceutical production areas the microbial count should be kept to a minimum to ensure the stability and cleanliness of drug products. In general, the conventional API and VITEK methods are used to characterize them. However, more and more frequently, microbiologists isolate "difficult" strains that such automated systems often fail to identify. Those "difficult" strains are often found in clean room areas, because the use of disinfectants leads to a change in the metabolic pattern and so the conventional methods provide wrong results. The author, Sandra Tscherwizek, shows an opportunity to identify such ¿difficult strains¿ via a 16S rRNA gene sequencing method based on the genetic level, and describes how to interpret the outcome. Furthermore a cost-benefit calculation was done to compare the conventional methods Vitek and API with the sequencing method. The study shows that an identification of microorganisms by 16S rRNA gene sequencing leads to higher resolution power compared to conventional biochemical methods.