Phone: +385 1 8886300

Email: fidelta@glpg.com

  • Bioanalysis usually refers to the quantitative measurement of a compound in a biological matrix from in vivo studies (e.g. blood, plasma, urine, tissues) and in vitro studies (e.g. cell lines, microsomes, hepatocytes). A bioanalytical method typically includes the extraction of the compound from a biological matrix (sample preparation) and the detection of the analyte via a combination of chromatography techniques  (HPLC or UPLC) coupled to a mass spectrometer.

  • Selective and sensitive analytical methods are critical to sound quantitative evaluations of drugs and metabolites.  Fidelta has extensive capability, expertise and experience in the field of bioanalysis and routinely provide quantitative analytical support for in vitro and in vivo ADME/PK, as well as in vitro and in vivo pharmacology and toxicology studies in discovery and early development.

  • Rapid turnaround quantitative analysis is ensured through efficient sample preparation, state-of-the art LC-MS/MS systems  and a dedicated instrument maintenance team.  All studies are performed according to SOPs and are in line with EMA and FDA bioanalytical guidelines and white papers. Protocols can be further customized in order to fit all requestor’s need.

  • Fidelta has a well built logistical support for receiving material and biological samples world-wide.

  

Method development

The development of an LC-MS/MS method requires optimizing three separate methodologies:

  • MS/MS method development
  • Chromatographic separation
  • Sample preparation method (e.g. protein precipitation, solid-phase extraction or liquid-liquid extraction)

State-of-the art technologies
Rapid sample turnaround

High quality data

  

High-throughput bioanalysis

  • supported through DiscoveryQuant, a state of the art plugin that enables batch based compound optimization and rapid method and batch creation, including results review and reporting


 


Figures 1 & 2. Typical 8 point calibration curve and IS overall Area plot (dashed line denotes acceptance criteria)


We are committed to providing high quality and timely data.

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