Related Experiment Video
Updated: May 19, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
European Bioanalysis Forum recommendation on method establishment and bioanalysis of biomarkers in support of drug
Philip Timmerman1, Christian Herling, Daniela Stoellner
1Janssen Research & Development. ptimmerm@its.jnj.com
Abstract:
Biomarkers have become increasingly important in drug development and many bioanalysts are getting involved. Consequently, different views on how to approach the bioanalysis of biomarkers have been published or are being developed. The European Bioanalysis Forum has intensively discussed this topic since 2010 and is ready with their recommendation on method establishment and bioanalysis of biomarkers. Acknowledging that the challenges step outside the bioanalytical laboratory is a cornerstone of our recommendation. The importance of integrating all scientific aspects, from purely analytical aspects, all the way to understanding the biology and effects of the biomarker, prior to embarking on method establishment or sample analysis, cannot be underestimated. Close and iterative interactions with the teams requesting the data is imperative to develop a bioanalytical strategy that combines science, analytical performance and regulations. The European Bioanalysis Forum developed a straightforward decision tree to help the scientific community in developing a bioanalytical strategy for any biomarker in drug development.
Related Concept Videos
Therapeutic Drug Monitoring: Drug Analysis Methods
Measurement of Bioavailability: Pharmacodynamic Methods
Drug Concentrations: Measurements
Plasma —...
Clinically Relevant Drug Product Specifications: Methods of Establishment
Measurement of Bioavailability: Pharmacokinetic Methods
Bioavailability Study Design: Healthy Subjects Versus Patients

