test FACILITY

Director Dr. Luigi Marvasi

The Biogem Test Facility got the first Good Laboratory Practices (GLP) certification from the Italian Ministry of Health in 2019.

GLP standards apply to non-clinical studies aimed at assessing the safety of drugs, chemical products, medical devices, veterinary drugs, agropharmaceuticals in relation to living beings and the environment.

GLP studies aim to get high quality and reliability experimental data, in compliance with the requirements of the Regulatory Authorities for the authorization to commercialize new products.

The GLP standards were adopted by the OECD to promote data quality and to make possible their acceptance at an international level among the different countries.

In Italy GLP is regulated by Legislative Decree No. 50 of March 2007 implementing the directives 2004/9/EC and 2004/10/EC.

The objectives of the GLP Biogem Test Facility are:

· To offer its professionality to companies in order to implement the safety and competitiveness of new products for greater protection of public health.

·To offer technical and scientific support for appropriate study design, its execution, the processing of experimental data, and the final reporting.

Access to the facility is strictly controlled and permitted exclusively to authorized personnel, subject to digital identification.

The GLP Biogem Test Facility has laboratories, operating units, equipment and dedicated archives to adequately perform all the experimental phases required by relevant international regulations and guidelines for the execution of pre-clinical studies.

The Operating Units/Laboratories which perform the activities of Biogem Test Facility are:

·Animal Facility: it is dedicated to the in vivo phase of regulatory studies with different rooms for housing rodents (rats and mice) and rabbits, and laboratories for the collection of biological samples.

·Formulation Laboratory: it is dedicated to the preparation of used formulations (solutions, suspensions, emulsions, etc.) and to the storage of test products in controlled conditions in order to guarantee their stability.

·Histopathology Laboratory: it is dedicated to the preparation of histopathological preparations and their microscopic evaluation.

·Hemato-biochemistry Laboratory: it is dedicated to hematological and biochemical analyses on blood samples and serum, and to urine analyses.

- Molecular Biology Laboratory: it develops and validates molecular biology analytical methods and it performs molecular analyses on nucleic acids and proteins from cells and samples of tissues and biological matrices.

·Bioanalytical Laboratory: it develops and validates chromatographic analytical methods: HPLC-MS /MS, HPLC-UV.

·Cell Culture Laboratory: it is dedicated to the cytotoxicity evaluation of the products under investigation and the isolation of new primary cell lines.

·Quality Assurance: it is dedicate to guarantee that the test facility and the experimental studies are managed in compliance with the GLP standards.

·Archive: room with limited access in which material and data from experimental studies as well as documentation concerning the test facility are archived.