The Bioanalytical Laboratory conducts quantitative analysis of preclinical and clinical pharmacokinetic and biomarker samples in a GLP-certified environment.
The Bioanalytical Laboratory has validated methods for the quantitative analysis of many pharmaceuticals, drug metabolites, hormones and other biomarkers in biological and other samples. New analytical methods are developed and validated based on the needs of our customers and collaboration partners, and according to the guidance of the EMEA and the FDA on bioanalytical method validation. The Laboratory can perform small-scale pilot projects in the preclinical development phase of a new chemical entity, during early clinical trials and during formulation development, but is also equipped to manage larger multi-centre projects as a central laboratory
Sample matrices include serum, plasma, whole blood, dry blood spots, urine, tissues, saliva, cerebrospinal fluid, formulations, surface swabs and environmental samples.
The Bioanalytical Laboratory conducts qualitative and quantitative analysis of molecules of interest from different matrices (biological or environmental samples, different types of products of the chemical industry) with high sensitivity and quality in a GLP-certified environment.
A biomarker may be any substance used as an indicator of a biological state. It is a characteristic that is objectively measured and evaluated as an indicator of normal or pathological biological processes, or pharmacologic responses to an intervention.
The Bioanalytical Laboratory is GLP-compliant. It is regularly inspected by the Finnish Medicines Agency (Fimea). This qualifies the Laboratory to perform bioanalyses for regulatory non-clinical and chemical safety studies. Sample analysis for clinical trials on pharmaceuticals is conducted in accordance with GLP and GCP.