Application of a Riboprinter® for Microbiological Control in Pharmaceuticals

There is a regulatory expectation for use of genotypic identification methods for certain types of isolates from pharmaceutical manufacturing events (such as media fill or sterility test failures). This is especially so if an attempt is to be made to invalidate a test. An example of such a system, which provides genotypic identification and the ability to match organisms based on genetic similarity, is the RiboPrinter. The RiboPrinter technology has an additional advantage to aid pharmaceutical microbiologists – it can match organisms, to show genetic level similarity and this is something that can proof invaluable with root cause analysis.

The commercialization of the technology led to the DuPont™ RiboPrinter® System, which automates restriction fragment length polymorphism (RFLP) analysis and targets the rRNA-coding region of the bacterial genome.

This article outlines the Riboprinting technology and discusses some applications of the approach, which can assist within investigations within the pharmaceutical context.

The reference is:

Sandle, T. (2019) Application of a Riboprinter® for Microbiological Control in Pharmaceuticals, Journal of GxP Compliance, 23 (6): http://www.ivtnetwork.com/article/application-riboprinter%C2%AE-microbiological-control-pharmaceuticals

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)