Preclinical hazard evaluation strategy for nanomedicines

Area of Science:

• Nanomedicine Safety and Toxicology
• Biomaterials Science
• Regulatory Science

Background:

• Growing use of nanomedicines necessitates robust safety evaluations.
• Current hazard assessments are often case-by-case, considering material properties, biological interactions, and toxicological responses.
• Regulatory bodies emphasize route of exposure and intended use in nanotherapeutic safety.

Purpose of the Study:

• To introduce a novel, unique evaluation strategy for nanomedicine safety.
• To focus on spherical engineered nanoparticles for parenteral administration.
• To provide a framework for application-oriented classification and decision-making in nanotherapeutic development.

Main Methods:

• Development of a three-tiered Hazard Evaluation Strategy (HES) for injectable nanoparticles.
• Utilizing standardized assay protocols from the US and EU Nanotechnology Characterization Laboratories.
• Focusing on cellular uptake and intracellular persistence as key indicators of hazard potential.

Main Results:

• The HES provides a robust framework based on physicochemical characterization, nanoparticle (bio)interactions, and hazard assessment.
• The strategy integrates regulatory specifications from agencies like the EMA and FDA.
• The methodology is unique, employing exclusion criteria for hazard evaluation.

Conclusions:

• The proposed HES is a cost-effective and adaptable strategy for evaluating the safety of injectable nanomedicines.
• It aids in the design and optimization of nanotherapeutics.
• This represents the first hazard evaluation strategy specifically designed for nanotherapeutics.