• BIOLOGICAL SAFETY ASSESSMENT & BIOCOMPATIBILITY TESTING according to ISO10993-5, ISO10993-4, ISO10993-23 and in vitro sensitization test according to OECD442D and OECD442E.
• 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.
• 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
• 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.
• ADVANCED CELL THERAPIES AND REGENERATIVE MEDICINE
• PARTICLE COUNT ON FILTER
• MOLECOULAR BIOLOGY INVESTIGATIONS: Gene Expression evaluation by real-time PCR, acid nucleic extraction from cell cultures, tissues and 3D cell cultures
• HISTOLOGY INVESTIGATIONS: the lab is equipped for paraffin embedding of biological specimens, paraffin section staining, immunohistochemistry and immunofluorescence techniques.
• SCIENTIFIC MANUSCRIPTS, ETICHAL COMMIETTES AND PATENTES
  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
• 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

Identification of the cell-biomaterial combination, which allows the differentiation towards a target tissue.

MAB has experience in:

• pre-clinical studies for the regeneration of bone and adipose tissue
• Writing and submission of studies to the ethics committee for in vivo experiments
• In vivo damage simulation of human pathologies and treatments  with stem cells and biomaterials in autologous, allogeneic and xenogenic settings
• assessment of the implant through histological investigations

The advanced microscopy branch of the MAB laboratory is able to answer to different company needs through :

• histopathological investigations for the physio-pathological characterization of tissues
• surface studies of materials by large surfaces scanning with high resolving power and  reconstruction of the image in three dimensions
• biomaterials colonization with fluorescent cells
• image analysis to transform qualitative data into a semi-quantitative survey

We deliver tailor made approaches through:

• creation of three-dimensional models of bacterial biofilms on biomedical devices for the evaluation of sterilization processes or new functionalizations of surfaces,  in vivo and in vitro.
• biochemical tests for the study of inflammatory processes in various stages of treatment.
• blood simulation models to detect possible blood parameters changes in and activation of coagulation processes.
• functionalization and characterization of membrane performances for biomedical devices.
• support  in the R & D phases.

It is possible to evaluate the bacterial biofilms formation on a biomedical device through in vitro and in vivo investigations, monitoring the same animal with in vivo imaging. Microscopy techniques can also be applied to study the biofilm distribution in the device.