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1 Frazione Pantalla di Todi Perugia - Italia Tel: /

2 About Us About Us About Us

3 BIOTECNOLOGIE BT srl Frazione Pantalla di Todi Perugia - Italy Phone: / Fax: Alessia Aguzzi Business Development Manager aaguzzi@biotecnologiebt.it Mobile: Phone: (ext. 102) Giorgio Freschi Scientific Director gfreschi@biotecnologiebt.it Mobile: Phone: Stefania Morandi BioTecnologie BT Research Centre Manager smorandi@biotecnologiebt.it Mobile: Phone: (ext. 259) Antonio Pandolfi BioSpheres Research Centre Manager apandolfi@biotecnologiebt.it Mobile: Phone: About Us Biotecnologie BT is an Italian Contract Research Organization (CRO), certified in Good Laboratory Practice (GLP) and Good Experimental Practice (GEP). Biotecnologie BT, with its two Test Facilities, situated in Central and Northern Italy, is able to provide services in support of the registration dossier in EU, USA and South America of different kind of products: Plant Protection Products Biocides Chemicals Veterinary Medicinal Products Pharmaceutical Products Performing a wide range of tests on the chemical-physical, ecotoxicological (terrestrial and aquatic), microbiological field, efficacy evaluation and residual analyses. All tests are performed in compliance with current International Guidelines (OECD, OPPTS, IOBC/WPRS, ESCORT, CIPAC, ISO, ICH, ASTM international, EPPO, Lundhen Document, EFSA Guidance Documents, VICH, etc.) BioTecnologie BT, thanks to a long experience, consolidated know-how, highly qualified staff and cutting edge equipment, can guarantee a quality performance to suit customer needs. "What we have to learn to do, we learn by doing" Aristotele

4 CROs CROs CROs

5 Biotecnologie BT CRO: Located in Pantalla di Todi, Perugia Central Italy, holds an expe- rienced staff with degrees in Chemistry, Biology, Agronomy, Natural Sciences. This Research Centre is specialized in environmental impact assessment of chemical and biological plant protection products, veterinary medicines and biocides. It has developed a strong internal know-how to evaluate, in laboratory and in greenhouse, the efficacy of different types of products vs different targets. Moreover, the CRO over the years has achieved a proven experience in the field of GLP studies applied to products based on microorganism (bacteria, fungi, yeasts and viruses). This laboratory was authorized to work in GLP by Italian an Ministry of Health since 2005 and carries out the following full range of activities: Terrestrial and aquatic ecotoxicological studies Physical chemical c a characterization Analytical methods Microbiological tests Laboratory ry and greenhouse screenings Environmental nt fate and behaviour studies Biospheres CRO: Located in Lodi Northern Italy, has an experienced staff with degrees in Chemistry, Biology, Biochemistry and Agronomy. This Test Facility has a long and consolidated experience in the field of agrochemical, chemical and xenobiotic otic products. This laboratory was authorized by Italian Ministry of Health and Italian Ministry of Agriculture, Food and Forestry, to work in GLP and GEP respectively since 1995 and carries out the following full range of activities: Physical chemical properties Analytical methods Efficacy field trials Residue trials Studies on processed matrices Environmental fate and behaviour studies

6 Plant Protection Products (PPPs) including Biopesticides Plant Protection Products Plant Protection Products

7 PLANT PROTECTION PRODUCTS (PPPs) including Biopesticides Plant Protection Products (PPPs) are active substances and preparations containing one or more active substances, intended to be used for the protection of the plants or plant products against all pests or to prevent their action, to promote or to regulate the plants life processes, to preserve plant products and to control weeds growing. In June 2011 was adopted a new regulation (Reg. EC 1107/2009) which lays down harmonized rules for the approval of active substances and the placing on the market of plant protection products. The main changes introduced are the cut-off criteria for an exclusion beforehand of the hazardous substances, a simplified authorization procedure for the substances identified as low risk and the zonal authorization of the products for the mutual recognition in the European Union Member States. Our services: Active ingredient content Relevant/significant impurities contents including contaminants evaluation Analytical profile of batches Biochemical and molecular strain identification of microorganisms (for Biopesticides) Physical-chemical and technical properties Physical hazards and respective properties Set up and validation of analytical methods Residues in or on treated products, food and feed (field trials and analytical laboratory determinations) Laboratory and greenhouse screenings Effectiveness trials including the evaluation of the adverse effects Environmental fate and behaviour (soil, water and sediments) Ecotoxicological studies: - Toxicity to Aquatic organisms: Fish, Daphnia magna, Fresh water Algae and Cyanobacteria, Macrophytes (Lemna spp. and Myriophyllum spicatum) - Toxicity to Terrestrial organisms: Non Target Arthropods, Honeybees Non Target Plants Soil micro and macro-organisms

8 Biocides Biocides Biocides

9 Biocides A Biocide is a product which has the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by chemical or biological means. In September 2013 entered in force the new Biocidal Products Regulation (BPR, Regulation EC 528/2012) which improves the free movement of these products within the European Union and assures a high level of protection of both human and animal health and the environment. BPR covers very different product types grouping them in four main classes: Disinfectants, Preservatives, Pest control and Others. Our tests: Physical-chemical and technical properties Physical hazards and respective properties Set up and validation of analytical methods Efficacy test Main group I: Disinfectants Main group III: Pest control Environmental fate and behaviour (soil, water and sediments) Ecotoxicological studies - Toxicity to Aquatic organisms: Fish, Daphnia magna, Fresh water Algae and Cyanobacteria, Macrophytes (Lemna spp. and Myriophyllum spicatum) - Toxicity to Terrestrial organisms: Non Target Arthropods, Honeybees Non Target Plants Soil micro and macro-organisms

10 Chemicals Chemicals Chemicals

11 Chemicals A substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. The Chemical Substances are ordered by the Regulation EC 1907/2009, based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. Its provisions are underpinned by the precautionary principle. Our services: Degree of purity Percentage of (significant) main impurities Physical-chemical and technical properties Physical hazards and respective properties Set up and validation of analytical methods Environmental fate and behaviour (soil, water and sediments) Ecotoxicological studies - Toxicity to Aquatic organisms: Fish, Daphnia magna, Fresh water Algae and Cyanobacteria - Toxicity to Terrestrial organisms: Soil Invertebrates, Non Target Plants Soil micro and macro-organisms

12 Veterinary Medicinal Products (VMPs) Veterinary Medicinal Products Veterinary Medicinal ProductsW

13 Veterinary Medicinal Products (VMPs) A Veterinary Medicinal Product (VMP) is defined as any substance or combination of substances presented for treating or preventing disease in animals. Any substance or combination of substances which may be administered to animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals is likewise considered a veterinary medicinal product. The basic rules governing the marketing of Veterinary Medicinal Products within the European Union is the Directive 2001/82/EC, the current legislation requires that an Environmental Risk Assessment (ERA) is provided for each new application, including generics. Our services: Physical-chemical properties Contaminants evaluation Environmental fate and behaviour (soil, water and sediments) Set up and validation of analytical methods Residue determination on foodstuffs of animal origin Ecotoxicological studies: - Toxicity to Aquatic organisms Fish, Daphnia magna, Fresh water Algae and Cyanobacteria, Macrophytes (Lemna spp. and Myriophyllum spicatum). - Toxicity to Terrestrial organisms Non Target Arthropods, Honeybees Non Target Plants Soil micro and macro-organisms

14 Pharmaceutical Products Pharmaceutical Products Pharmaceutical Products

15 Pharmaceutical Products A Medicinal product is defined as any substance or combination of substances presented for treating or preventing disease in human beings. Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product. Medicinal products are regulated by the Directive 2001/83/EC. According to the implementation of this Directive the evaluation of the potential environmental risks posed by medicinal products should be submitted, their environmental impact should be assessed and, on a case-by-case basis, specific arrangements to limit the impact should be considered. Our services: Physical-chemical properties Contaminants evaluation Set up and validation of analytical methods Environmental fate and behaviour (soil, water and sediments) Ecotoxicological studies - Toxicity to Aquatic organisms Fish, Daphnia magna, Fresh water Algae and Cyanobacteria - Toxicity to Terrestrial organisms Soil Invertebrates, Non Target Plants Soil micro and macroorganisms

16 A quick view on our tests A quick view on our tests V A quick view on our tests

17 Identity of the product/active Substance Content of the active substance Content of the relevant impurities Content of the significant impurities Analytical profile of batches Physical, chemical and technical properties Appearance Acidity/Alkalinity Relative density and bulk density Storage stability, stability and shelf Life Technical characteristics based on the product type Physical and chemical compatibility with other products Degree of dissolution and dilution stability Surface tension Viscosity Water solubility Dissociation constants in water UV-VIS Absorption Spectrum Melting Point/Melting Range Kow partition coefficient Physical hazards and respective characteristics Flammability and auto-flammability Explosive and oxidizing properties Analytical methods Fully equipped analytical laboratory HPLC/UV-VIS, HPLC/DAD, LC/MS-MS, UPLC/MS-MS, ICP-MS, GC/FID and µecd, GC/MS, etc. Method set-up and validation Residue analysis Certificates of Analysis (CoA) Independent Laboratory Validation (ILV) Residues in or on treated products, food and feed Magnitude of residues in rotational crops Storage stability of residues Magnitude of the pesticide residues in processed commodities Residues in or on raw agricultural commodities-crop Field trials Efficacy tests Effectiveness trials Adverse effects on the treated crops Phytotoxicity to target plants or to target plant products Effects on the yield of treated plants or plant products Effects on the quality of plants or plant products Effects on transformation processes Impact on treated plants or plant products to be used for propagation Observations on other undesirable or unintended side-effects Ecotoxicological studies/toxicity to aquatic organisms Short-term fish toxicity test Acute immobilisation/reproduction test on Daphnia magna Growth inhibition test on Freshwater Alga and Cyanobacteria Growth inhibition test on Lemna spp. Sediment-free/Water-sediment Myriophyllum spicatum toxicity test Biodegradation - Activated sludge respiration inhibition Ecotoxicological studies/toxicity to Terrestrial organisms Soil micro-organisms, Nitrogen and Carbon transformation test Earthworms, acute toxicity/reproduction test Predatory soil mites, Hypoaspis aculeifer reproduction test in soil Springtails, Collembolan (Folsomia candida) reproduction test in soil Non-target arthropods Aphidius rhopalosiphi, Typhlodromus pyri, Aleochara bilineata, Poecilus cupreus, Chrysoperla carnea, Coccinella septempunctata, Orius laevigatus, Pardosa sp. Terrestrial plants, seedling emergence and seedling growth test and vegetative vigour test Honeybees, acute oral/contact toxicity test Honeybees, chronic adult 10 days oral toxicity test Honey bees, larval toxicity test, single/repeated exposure Bumble bees, acute oral/contact toxicity test Environmental fate and behaviour Ready biodegradability Adsorption-desorption using batch equilibrium method Estimation of the adsorption coefficient on soil and on sewage sludge using HPLC Aerobic and anaerobic transformation in aquatic sediment systems/soil Photolysis Hydrolysis Specific activities on the products based on microorganisms (bacteria, fungi, yeasts and viruses) Biochemical and molecular strain identification Sensitivity test to antibiotics/antifungals and Calculation of the Minimum Inhibitory Concentration (MIC) Method set-up and validation for the microorganism content determination Identity and content of impurities including the determination of the microbial contaminants and metabolites Analytical profile of batches The list of our tests should not be considered definitive, but constantly updated according to regulatory requirements and scientific improvements, so please contact us for any further information.