Abstract
The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.
Highlights
The convergence of nanotechnology and biotechnology has created huge potential for advancements in medical diagnosis, therapy and regenerative medicine, which has fostered large investments in developing novel nano-biomaterials (NBMs) for use in medical devices (MD) and in medicinal products, including advanced therapy medicinal products (ATMP)
The main goal of this paper is to propose an overarching framework for risk management of NBMs used in MD and ATMP, which complements the preclinical benefit-risk analysis of these technologies with a complete assessment of their risks for the environment as well as for medical professionals and workers exposed to NBMs during production, use and/or end-of-life treatment
We provided an overview of the BIORIMA risk management framework (RMF) in conceptual terms
Summary
The convergence of nanotechnology and biotechnology has created huge potential for advancements in medical diagnosis, therapy and regenerative medicine, which has fostered large investments in developing novel nano-biomaterials (NBMs) for use in medical devices (MD) and in medicinal products, including advanced therapy medicinal products (ATMP) (cf. definitions in SI Section 1). NBMs are a special category of biomaterials, which possess a constituent or have a surface dimension in the nano range (i.e., 1–100 nm) [1] These new materials can offer unprecedented technological benefits as their interactions with the biological systems can improve biocompatibility as well as clinical efficacy, while reducing adverse effects [2,3,4,5]. Because of their more complex nature and nano-bio/eco interactions (i.e., interactions of the nano-sized component with biological molecules and structures, and with the surrounding environmental media in case of release in the environment), there are both scientific and societal concerns about their possible health and/or environmental risks. It is challenging to propose effective risk management strategies in accordance with the regulatory requirements legally enforced to ensure their safety, efficacy and quality [6,7,8,9]
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