Pharmacelsus – Success Story 3

Pharmacelsus provides cost-efficient quantification of small amounts in a single LC/MS run by cocktail analysis

Challenge

Pharmacelsus has been challenged in several projects to quantify in a fast and cost-efficient way smallest amounts in samples generated in in vitro and in vivo studies or from clinical trials.

Idea

Pharmacelsus designed a cocktail approach which allows quantification of a set of compounds in a single LC/MS run.

Solution

Pharmacelsus is equipped with a Q-Exactive LC-MS/MS that combines high-performance quadrupole precursor selection with high resolution (up to 140,000), accurate mass detection (Orbitrap) and fast scan-to-scan polarity switching feature in both MS and MS/MS mode. Using the Q-Exactive, unique types of cocktail analyses were qualified and launched to analyse bile acids, their metabolites, and CYP probe reactions.

Results: Bile Acids

Using a high resolution mass spectrometry approach, Pharmacelsus succeeded in quantifying 15 major bile acids and the corresponding metabolites with lower limits of detection in the ng/mL range out of one sample. Thus pathological changes in bile acid secretion and/or profile can be detected much earlier in the drug development process in a fast and cost-efficient way.

Results: CYP Probe Analysis

Another application for the Pharmacelsus cocktail approach is the analysis of CYP probes from functional activity screening of CYP isozymes. Pharmacelsus succeeded in quantifying the 8 most important, FDA- and EMA recommended CYP probes with lower limits of detection in the range of 1 to 6 nM out of one sample. Thus drug-drug interactions can be detected much earlier in the drug development process in a fast and cost-efficient way.

Perhaps it is not about getting the cheapest or fastest CRO, but about getting results from a CRO, who is on the front lines of assay development!