TY - JOUR A1 - Abram, Sarah-Luise A1 - Tavernaro, Isabella A1 - Resch-Genger, Ute A1 - Johnston, L. J. A1 - Zou, S. T1 - Nanoscale reference and test materials for the validation of characterization methods for engineered nanomaterials — current state, limitations, and needs N2 - The rational design of engineered nanomaterials (NMs) with improved functionality and their increasing industrial application requires reliable, validated, and ultimately standardized characterization methods for their application-relevant, physicochemical key properties such as size, size distribution, shape, or surface chemistry. This calls for nanoscale (certified) reference materials (CRMs; RMs) and well-characterized reference test materials (RTMs) termed also quality control (QC) samples, assessed, e.g., in interlaboratory comparisons, for the validation and standardization of commonly used characterization methods. Thereby, increasing concerns regarding potential risks of NMs are also addressed and the road for safe and sustainable-by-design concepts for the development of new functional NMs and their use as nanomedicines is paved. With this respect, we will provide an overview of relevant international standardization and regulatory activities, definitions, and recommendations on characterization methods and review currently available organic or inorganic nanoscale CRMs, RMs, and RTMs, including their characterization or certification. In addition, we will highlight typical applications to streamline the regulatory approval process and improve manufacturability including the special challenges imposed by the colloidal nature and sometimes limited stability of NMs. Subsequently, we will critically assess the limitations of currently available nanoscale RMs and RTMs and address the gaps to be filled in the future such as the availability of NMs that come with reference data on properties other than commonly addressed particle size, such as surface chemistry or particle number concentration, or more closely resemble commercially available formulations or address application-relevant matrices. KW - Nano KW - Particle KW - Silica KW - Quality assurance KW - Reference material KW - Review KW - Surface chemistry KW - Size KW - Shape KW - Particle number concentration KW - Lipid nanoparticles KW - Metal nanoparticles KW - Liposomes PY - 2025 UR - https://nbn-resolving.org/urn:nbn:de:kobv:b43-625746 DO - https://doi.org/10.1007/s00216-024-05719-6 SN - 1618-2650 SP - 1 EP - 21 PB - Springer AN - OPUS4-62574 LA - eng AD - Bundesanstalt fuer Materialforschung und -pruefung (BAM), Berlin, Germany ER -