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Bioanalysis is used for assessments of efficacy, metabolism, kinetics, and toxicity. We have the expertise required to select, validate and measure adequate biomarkers for your study. RISE ensures quality throughout the bioanalytical chain; sampling, sample handling, sample preparation, analysis, evaluation and qualified interpretation of data.
We use bioanalysis for qualitative and quantitative measurements of substances in biological materials, among other things to determine the systemic (blood) or local exposure in a tissue to a drug and its metabolites. When developing a new drug, it is important to know where the drug is distributed in the body and to quantify the drug and its metabolites in the body. This data can be used to help assess and interpret the drug's effectiveness and toxicity as well as help assess the clinical effects and adverse events of the drug.
The blood concentration of the active drug is often very low. At the same time blood components can interfere with the analysis. Therefore, we use analytical methods that are ultra-sensitive and specific for the substance in question to determine its blood concentration. In our bioanalytical lab, we have state-of-the art equipment such as gas chromatography (GC) or liquid chromatography (LC) that is coupled to different types of mass spectrometers (MS & MSMS).
We are experts in developing novel and optimized methods that are validated in accordance with current regulations from the pharmaceutical regulatory authorities such as EMA and FDA. Our laboratory can be used for studies that require GLP and GCP to perform preclinical and clinical regulatory studies prior to registration and approval.
Our analysis techniques can be useful throughout the drug developmental process. For example, we use our methods to determine the degree to which a drug binds to proteins in the blood, how quickly a drug is metabolized, and which metabolites are formed. The bioanalytical results are useful in non-clinical pharmacokinetic (PK) and toxicokinetic (TK) calculations. By combining data from in vitro assays and in vivo studies a safe initial dose can be estimated for use in clinical trials.
Targeted analysis is used in studies when you know in advance which substance is to be determined. We also have the expertise to profile samples unconditionally, non-targeted analysis. We use high-resolution tandem mass spectrometry and in complex cases, and if needed, using an additional dimension of separation, so-called ion mobility. Areas of use can be evaluation of new biological mechanisms, for example validation of new targets, discovery and qualification of new biomarkers and diagnosis for future treatment (precision medicine).
To meet clients in their research on or production of proteins, enzymes, biologicals, antibodies, oligonucleotides and other new therapies, our bioanalysis lab is well equipped to characterize these products with respect to property, function, heterogeneity, and impurity profile.
There are requirements regarding the environmental life cycle of a drug. Based on ecotoxicological studies on drugs, their metabolites, drug degradation, drug degradation products, and its persistence in the environment, environmental risk assessments can be conducted. We have a panel of about 20 different drugs relevant to environmental hazards. Our laboratory is capable of measuring the spread of drug residues to different recipients or wastewater treatment plants. By comparing drug levels in the incoming and outgoing water of wastewater treatment plants, we can determine the treatment effectiveness.
Narcotics can be licensed pharmaceuticals or illegal drugs. Measuring narcotics, such as amphetamine, opioids and cannabis, and/or its metabolites in wastewaters makes it possible to estimate its use over time; provide a trend in opioid use in a geographic area or workplace. Our analytical methods have been validated through an intercalibration study within the SCORE research network, which is responsible for organizing annual European multi-city wastewater studies used to estimate the narcotic consumption.
Welcome to contact us if you need a speaking partner within the bioanalysis field.