1

BIOLOGICAL SAFETY ASSESSMENT & BIOCOMPATIBILITY TESTING

According to ISO10993-5, ISO10993-4, ISO10993-23 and in vitro sensitization test according to OECD442D and OECD442E.

2

DESIGN AND DEVELOPMENT OF ADVANCED BIOLOGICAL MODELS FOR BIOCOMPATIBILITY STUDIES

2D cultures or Bioprinting are applied for the development of customized models to investigate the efficacy and safety of drugs and medical device, in order to highlight performance and critical aspect reducing time to market. MAB lab has skills in cell culture isolation form healthy and pathological tissues and know-how on isolation, characterization and culture of mesenchymal stroma cells from multiples tissue and species.

3

INTERACTION CELL-MATERIAL

3D cell cultures are performed on biomaterials and medical device to evaluate citotoxicity and biocompatibility. The dual interaction between cells and biomaterials among the development of specific tissue is investigate thanks to advanced microscopic technologies.

4

BIOPRINTING

In collaboration with the MS2 laboratory, it is possible to print both cells and materials to obtain innovative cellular and tissue models able to mimic the physiology of organs and tissues. The ultimate goal is to predict safety, biocompatibility and effectiveness of new therapeutic approaches.

5

ADVANCED CELL THERAPIES AND REGENERATIVE MEDICINE

6

PARTICLE COUNT ON FILTER

7

MOLECULAR BIOLOGY INVESTIGATIONS

Gene Expression evaluation by real-time PCR, acid nucleic extraction from cell cultures, tissues and 3D cell cultures.

8

HISTOLOGY INVESTIGATIONS

The lab is equipped for paraffin embedding of biological specimens, paraffin section staining, immunohistochemistry and immunofluorescence techniques.

10

SURFACE CHARACTERIZATION AND PARTICLE COUNT

Staining and advanced optical microscopic combined with electronic microscopic (SEM), IR and chemistry interface (XPS) are applied to investigate the material surface.

11

DETECTION OF BLOOD CELLS AND/OR BIOFILM ON A MATERIAL

Histology approaches are applied to a medical device to characterize the distribution of blood cells and clots or bacteria biofilm in a medical device after ex-vivo use to prevent critical aspects during clinical application.

Simulation of biological models, biocompatibility assays and ad hoc hemocompatibility evaluate the effect, safety of materials as well as the performance of materials to remove/absorb specific substances

12

DESIGN AND VALIDATION OF MEASUREMENT SYSTEMS

Decades of experience in the development of measurement methods and systems. This expertise translates into consultancy that can range from simple technological scouting for the identification of commercial systems suitable for solving the specific measurement need, to the study, design and development of fully functional demonstrators that can be used for field tests and/or for demonstration purposes. The MS2 laboratory also has extensive experience in the technology transfer of the skills developed in order to support the customer up to the production of the developed object.

SUPPORTING LABS

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MS2