EDI (Experimental & Diagnostic Immunology) GmbH - PROFILE NO The company was founded in 1996 by Dr. Manfred Schmolz (PhD), the owner and general manager. The central goal of this certified CRO (EN ISO 13485) is to develop and provide high end, robust human organo-typical (HOT) cell culture test systems to customers from different areas. HOT systems are used for screening as well as in-depth profiling of compounds for bioactivity (drugs, nutraceuticals, food supplements, probiotics, cosmetics, as well as surface modifications of dialysis membranes, implant materials, etc.). HOT systems allow an unprecedented characterisation of a whole spectrum of bioactivities of compounds, lead substances and drug candidates, enabling an early prediction of relevant primary and secondary drug effects. By means of this a reliable picture of the activity pattern that can be expected to occur in vivo can be obtained already during pre-clinical R&D. Core business / services Contract research and development in the functional characterisation of immuno-biologically active substances or materials: Immuno-pharmacological and immuno-toxicological characterisation, primarily in highly standardised complex human cell culture models (HOT screening and HOT profiling) Contract development of customized cellular and non-cellular test systems, e.g. bioassays for quality control of recombinant proteins Consulting services around clinical trials for immunologically active drugs (anti-inflammatory, immuno-suppressive, immuno-potentiating, etc.) Moreover, we provide more than 20 years of extensive experience in the critical testing of complex biological materials (natural products, such as herbal extracts, probiotics, etc.) Products, methods, developments Primary goal of our company is to provide services and test systems for the investigation of not only single compounds, but also complex mixtures / final formulations (cremes, ointments, suppositories, etc.) under in vivo-like conditions. This was achieved by establishing different types of culture models, particularly co-culture systems comprising various cells types from different organs as well as cells of the human immune system in a co-operative fashion. All cellular tests can be performed to target immunopharmacological or immunotoxicological activities of the test substances in question. Another major break-through was the development of the patented TruCulture, an organo-typical whole-blood culture model for lab-independent, artefact-free on-site cultures in clinical trials enabling highly standardised in vivo-like testing of drug activities ex vivo. Moreover, we contract-develop and validate (FDA/CDER conform) non-cellular analytical test procedures based on immunoassays using various kinds of detection modes (luminescence, fluorescence, fluorescence-polarisaton, colorimetry). Besides this, we also offer to write development plans, project outlines, clinical trial plans (AMG, ICH, GCP), expert reports, etc.