“Bioanalysis in industry: LC-MS/MS and ligand binding assay”

Abstract:
Bioanalysis is an essential part of the development of novel drugs and, as integrated in the industry process, it 
must be regulated. It is the application of analytical methods to quantify drug levels, metabolites and biomarkers 
in biological samples. Regulatory guidelines and the implementation of quality standards, ensure the generation 
of reliable data on pharmacodynamics, pharmacokinetics, clinical safety and efficacy.
The two main techniques supporting the regulated bioanalysis are the LC-MS and the ligand binding assay (LBA), 
which cover a broad spectrum of drug classes: small molecules, oligonucleotides, peptides, proteins, mAbs, 
antibody-drug conjugates (ADCs). Although each technique can be directly associated to one drug class, the 
evolution of the expertise in Evotec, allowed to their alternative or synergic application to figure out the best 
bioanalytical strategies throughout projects.
When a drug candidate enters the regulated environment, it requires a thorough understanding of bioanalytical 
methods, interpretation of data, comprehensive reporting as well as the presence of a quality system and 
compliance with all regulatory requirements.
To provide an overview on the application of regulated bioanalysis in the industry, a case study on the ADC 
quantification will be presented.