Before a new drug can be used to treat a specific disease, it needs to be thoroughly investigated to ensure safety and efficacy. Bioanalysis is required to support this research. A few examples are given below:
- In order to support a (pre-)clinical study, drug concentrations are measured in biological fluids following administration of the drug. As the drug concentrations are often very low and the composition of biological matrices is complex, highly selective and sensitive analytical methods have to be developed and validated.
- Following administration of a drug, it can be transformed into metabolites. Research is required to investigate the metabolism of new drugs, as metabolites can be pharmaceutically active or even toxic. Metabolite investigations and chemical structure elucidation require highly-skilled analytical chemists and dedicated equipment.
- Therapeutic proteins are known to trigger an immune response following administration to the human body. The consequence of the immune response can vary from hardly any effect through to serious anaphylactic shock. Immunogenicity involves the analysis of the anti-drug antibodies. For each bio-pharmaceutical, new methods have to be developed and validated.
TRISKELION has the expertise and state-of-the-art instrumentation to perform all of these bioanalysis. Following sample pre-treatment, technologies used in bioanalysis include Ultra-Performance Liquid Chromatography (UPLC) combined with (high-resolution) Mass Spectrometry (MS), UV/VIS detection or fluorescence detection, ligand-binding assays (ELISA), Gas Chromatography (GC) combined with MS or Flame Ionization Detection (FID) and (high-resolution) Inductively Coupled Plasma-Mass Spectrometry (ICP-MS).
TRISKELION has many years of experience in pre-clinical and clinical bioanalysis, including method development, method transfer/implementation, method validation/qualification and sample analysis. If required, projects can be performed in compliance with Good Laboratory Practice (GLP) and according to the most recent EMA and FDA guidelines.