BIORIMA Latest News
In the light of increasing regulatory demands on the use of medical devices (MD) and advanced therapeutic medicinal products (ATMP), the EU funded BIORIMA project has taken a lead in developing an integrated risk management framework for the safe handling of nano-biomaterials (NBM) used in these medical applications. For the first time, it will be possible to assess and manage various risks that may arise from manufacturing and use of these novel materials along their life cycle and beyond clinical risks.
BIORIMA has initiated a comprehensive method testing and validation program to assess the robustness and applicability of current chemical, biological and modelling approaches ("test the test") to main types of NBM used in MD (e.g., as coatings in implants or protheses for tissue regeneration) and ATMP (e.g., for drug delivery or in vivo imaging/biosensing). Both industrial and lab-scale test materials including 1st, 2nd and 3rd NBM generations as metals/metal oxides, ceramics, hybrids, carbon based and organics, have been selected and are systematically characterized for human and environmental hazard and exposure.
The ongoing extensive testing campaign will throw new light on still unresolved questions on "where, when and how" these novel and increasingly complex and self-organized materials may be released along the value chain of a specific product into the environment, during or after production and medical application. Close identification and follow up of main exposure routes that NBM may take will provide us with the necessary scientific data to lift up our present understanding on their behavior, transport and final fate in the human body and ultimately in the environment. BIORIMA will create new insights into critical mechanisms that control their interaction with biological membranes and with body fluids in different cells, and how these processes may affect their final bio-compatibility or toxicity in exposed workers, patients or clinical personnel. Uncertainties still existing on possible risks associated with main exposure routes, such as inhalation, dermal uptake, ingestion or injection/implantation, and to the environment (air, water, soil and food web), will be further reduced and existing models updated to predict possible adverse effects and to increase the safety of medical applications. The newly produced scientific knowledge will ultimately contribute to a better understanding of the underlying physicochemical properties that govern the release and flow of nanostructured biomaterials, due to fracture, fatigue or tear, from the human body to the environment.