Tag: Analytical method development

Identity analytics: For cell-based therapies, the analytics, in addition to the process, are the product

Introduction As pharmaceutical drugs become physically larger, from small molecules to biologics to gene and cell therapies, so their molecular complexity increases. Small molecule drugs can be defined at the atomic level: it is known where each atom should be and how it should be connected to others. Methods are therefore developed to measure and continue reading…

How to successfully develop and validate molecular biomarkers for use in clinical trials

Diana Nijholt, Consultant Translational & Clinical Development

Introduction In our previous blog entitled ‘Biomarkers in early development‘, we highlighted the different types of biomarkers and their applications in (early) drug development. We discussed that biomarkers have the potential to speed up and enhance the chances of success of a clinical development program. A biomarker can, for example, define a patient subset most continue reading…