Sequencing

Especially when it comes to the causes of contamination in the manufacturing process, storage and transportation of medical devices. Reliable identification of the microorganism is also a decisive advantage in the troubleshooting process.

This means safety for manufacturers and patients.

Classical identification methods are based on the differentiation of the microorganism on the basis of morphological and physiological aspects, whereby the cell or colony is considered as a whole.

At the molecular level, in addition to phenotypic analysis (proteome spectrum) using a mass spectrometer (MALDI TOF), we also have the option of genotypic analysis using Sanger sequencing.

The genetic material of the cell as an analyte offers a well-founded information content and the use of GMP-validated databases enables maximum validity of the sequencing results with subsequent plausibility checks.

Guidelines:

• Ph. Eur. 2.6.2 Nucleic Acid Amplification Techniques (5.4 Detection)
• USP <1126> Nucleic acid-based techniques-Extraction, Detection and Sequencing.

We are happy to support you with your sequencing questions at
freigabe@gfps.de
.