FACILITY

Director Luigi Marvasi - PhD

The Biogem Test Center (CdS) is certified for Good Laboratory Practice (GLP) by the Ministry of Health after thorough assessment of technical-scientific skills and the adequacy of facilities and equipment available.

GLP compliance in studies and trials is necessary in order to guarantee the quality, safety and reliability of the experimental results, in accordance with the requests of the Regulatory Authorities for the approval of new products (drugs, food additives, detergents, pesticides and similar) for standards and regulators.

At Biogem GLP Test Center:

• we serve companies in testing the safety and competitiveness of new products in the interest of public health protection.
• we offer technical and scientific support in study design, from experimental design to reporting, and provide exhaustive and comprehensive information in the pre-market phase.

GLP test center

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

Access to the facility is strictly controlled and allowed only to authorized personnel, subject to digital identification or other security measures. The areas of relevance of the CdS are the following:

• Animal Facility: area reserved for regulatory studies with different rooms for the housing of rodents (rats and mice) and rabbits and laboratories for the collection of biological samples.
• Formulation Laboratory: management of the substance under study, of the relevant documentation and of the certificates of analysis, from receipt to storage in our Chemotheque. Preparation of formulations (solutions, suspensions, emulsions, etc.) and storage under controlled refrigeration conditions to ensure their stability.
• Pathology Unit: execution of necropsies, preparation of histopathological preparations and microscopic evaluation.
• Clinical Pathology Laboratory: hematological and biochemical analyzes on blood samples and urinalysis.
• Pharmacokinetics Laboratory: development, validation and optimization of the analytical method; quantitative determinations of samples in different biological matrices using the most up-to-date knowledge of chromatography and mass spectrometry (LC-MS / MS).
• Cell Culture Laboratory: characterization, biological activity, mechanism of action, cytotoxicity and toxicological profile of the molecules under study. Isolation of new primary cell lines.
• Archives: premises with restricted access where documents and artifacts relating to the various studies are kept, as well as the documentation pertaining to the CdS.