Ukrainian R&D center offers services in pre-clinical trials to European companies as CRO (contract research organization)

The Ukrainian R&D center has vast experience in the field of experimental pathology, biotechnology, and oncology and specializes in conducting complex preclinical studies of biologically active substances, pharmacological substances and medical products in accordance with world standards. Pre-clinical research іs performed in accordance with the requirements of Good Laboratory Practice (GLP). The scientific and methodological basis for conducting research are 4 Biotech centers and 5 working groups. Biotechnology Centers are certified and have all proper permissions. The basis for conducting in vitro research is the Bank of Cell Lines from human and animal tissues (more than 30,000 samples of typical and original cell lines from normal and tumor tissues of different animal species). Retention and breeding of laboratory animals is carried out in an experimental biological clinic (vivarium). The portfolio of preclinical studies includes the implementation of a wide range of tests of biologically active substances and medical devices in vitro and in vivo. Pharmacokinetics and pharmacodynamics studies include: - absorption distribution and deletion of the test substance Toxicological studies include: - toxicity with single administration (acute toxicity) and in repeated injections (subchronic and chronic toxicity) - immunotoxicity - carcinogenicity Antitumor activity studies include: - study of antitumor activity in a wide spectrum of tumors in vivo - definition of the range of therapeutic doses - determination of the optimal scheme of application - study of the efficacy of the test substance in combination with known antitumor drugs - study of antitumor activity with tumor with acquired drug resistance - study the ability of the test substance to suppress metastasis - study of the pharmacokinetics of the test substance in animals with tumors - determination of immunological and biochemical parameters - investigation of cytotoxic activity of the test substance in vitro. Studies on immunotoxicity and immunogenicity include: - evaluation of the influence of the test substance on the non-specific resistance of the organism, phagocytosis; on the humoral immune response;on the cellular immune response; on the proliferative activity of T-and B-lymphocytes; on apoptosis of lymphocytes; on the synthesis of cytokines, on the functional activity of natural killers. Investigation of carcinogenicity in chronic in vivo studies includes: - evaluation of carcinogenicity of test substance (two doses) in two species of both sexes (mice and rats with low frequency of spontaneous tumors) - estimation of latent period of occurrence of tumors and life duration of animals with tumors - evaluation of the pathomorphological and pathogistological characteristics of the experimental material The center seeks institutions, research centers, pharmaceutical and biotech companies who are interested in preclinical trials of biologically-active substances and medical devices. Partners could cooperate in the requested preclinical clinical trials. Contract form is services agreement.