Pharmacokinetic and biodistribution
The in vivo pharmacokinectic studies in rodents are of utmost importance in the drug development process and we are proud to offer a service that are including all phases of the studies, 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 presenting all information that will give an indication of the drugability of the candidates tested to give the best basis for efficacy testing in disease models and decision making as regard to the further process.
Animal disease models
The high aim of efficacy studies conducted with animal disease models is to prove the scientific rationale which is driving the drug development process. Biotest Facility offers studies with disease models in rodents for a wide range of diseases. The models will be rodent strains that are genetically predisposed for the disease or will be induced by chemical substances, immunoreactive treatment, surgery or special diets. Some of the disease models are not of-the-self products and regulatory work and validation of the models are conducted in advance of these studies.
The cancer disease models in mice are our special expertise. We have 10 years of continuous experience with xenograft studies including a range of variations of the model, e.g. SC, IV (disseminated) and orthotopic inoculation of the cancer cells. These studies include careful selection of the host animal and the donor cancer cells are originating from cultured cancer cell lines or from tumor tissue from patients (PDX). We can handle the administration of a variety of drug classes, including radioactive compounds, and administration via all the common administration routes.
Cell culture assays
The cell culture services is an integrated part of the xenograft product and we are offering growth inhibition assays, potency assays and cytotoxicity assays, e.g. 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 is ranging from the small chemical entities to large biological molecules as antibody-drug-conjugate and even complex mixtures of active components.