Pharmacokinetics and biodistribution
Pharmacokinectic studies in rodents are of utmost importance in the drug development process and we are proud to offer a service that includes all phases, from guidance concerning the study design, to conduct of the in vivo phase and analysis and interpretation of data. At Biotest Facility we have a thorough approach concerning recording and presentation of information. This provides the optimal indication of the druggability of the candidates tested, giving the best basis for efficacy testing in disease models and for decision making regarding the further process.
Animal disease models
The overall goal of efficacy studies conducted with animal disease models, is to prove the scientific rationale behind the drug development process. Biotest Facility offers studies with disease models in rodents covering wide range of diseases. The model rodent strains are genetically predisposed for certain disease or with a disease inducible by chemical substances, immunoreactive treatment, surgery or special diets. Some of the disease models are not of-the-shelf products, and regulatory work and validation of the models is conducted in advance of these studies.
Cancer disease models in mice is our special expertise. We have 10 years of continuous experience with xenograft studies, including a range of variations of the model, e.g. subcutaneous, intravascular (disseminated) and orthotopic inoculation of the cancer cells. These studies include careful selection of the ideal host animal strain for the specific donor cancer cells, which can be either cultured cancer cell lines or tumor tissue from patients (PDX). We can handle the administration of a variety of drug classes, including radioactive compounds, biologicals, and small molecule drugs, and we perform administration via all common administration routes.
Cell culture assays
Cell culture services is an integrated part of the xenograft product and we offer growth inhibition assays, potency assays, and cytotoxicity assays, as useful investigations of toxicity and efficacy before the first administration to an in vivo model.
We have experience with the formulation of drug candidates in vehicles which are compatible with the administration in rodents. This experience ranging from the small chemical entities to large biological molecules as antibody-drug-conjugates and even complex mixtures of active components. The facility is equipped for handling isotopes which are used to trace drug candidates in pharmacokinetic studies or used in efficacy studies testing drug candidates for radiotherapy.