Navigating the Translational Chasm: Advancing Nanoscale Materials to Clinical Realization

Nanoscale materials are a cornerstone of biomedical nanotechnology, offering unique opportunities to engineer interactions with biological systems through controlled size, composition, surface chemistry, and functional architecture. These capabilities have driven substantial advances in targeted delivery, imaging, and multifunctional platforms, particularly in complex biological contexts, such as tumors. However, the progression of these systems beyond laboratory-scale demonstrations remains limited. While material design principles to target desired cells or tissues are well established, their in vivo performance is often constrained by material-related factors, including physicochemical heterogeneity, dynamic nano–bio interactions, such as protein corona formation, and restricted transport across biological barriers. In parallel, challenges associated with poor reproducibility, scalable manufacturing, and regulatory alignment continue to hinder downstream development. Together, these issues highlight the need for integrated approaches that address both material design and translational readiness.This Research Topic aims to bring together the biomedical nanotechnology community to explore strategies that support the translation of nanoscale materials from early-stage research toward practical biomedical implementation. A key objective is to examine targeted delivery and tissue access from a materials-driven perspective, focusing on how intrinsic properties—such as size distribution, surface functionality, mechanical characteristics, and modular design—influence nano–bio interactions under physiologically relevant conditions. At the same time, the Topic recognizes that promising material systems frequently encounter barriers related to reproducibility, scalability, and alignment with regulatory expectations.By encouraging contributions that span materials science, nanofabrication, and translational considerations, this Research Topic seeks to promote realistic design and evaluation frameworks. Emphasis is placed on approaches that integrate biological complexity with standardized characterization, quality control, and manufacturing processes. Through this collective effort, the Topic aims to identify shared challenges, highlight emerging best practices, and support the development of nanoscale materials that are both innovative and translationally robust.This Research Topic welcomes Original Research articles, Reviews, Mini Reviews, and Perspectives that address material-centered strategies and translational enablers in biomedical nanotechnology. Contributions should emphasize mechanistic insight, quantitative analysis, and reproducibility, while maintaining clear relevance to a downstream biomedical application.Subthemes of interest include (but are not limited to):•Material design principles for targeted delivery to specific cells and tissues•Structure–function relationships governing nano–bio interactions•Transport across biological barriers, including the vascular endothelium, interstitial space, and cellular membranes •Biocompatibility assessment and nanotoxicology, with emphasis on standardized protocols •Surface functionalization, ligand presentation, and the dynamics of protein corona effects•Nanoscale materials for biomedical imaging and image-guided applications•Design of nanomaterials as contrast agents for optical, magnetic, nuclear, or multimodal imaging•Image-enabled evaluation of targeting efficiency, biodistribution, and nano–bio interactions•Theranostic and multifunctional nanoplatforms integrating imaging and targeting•Scalable and GMP-compatible nanomanufacturing approaches•Standardization, quality control, metrology, and regulatory science•Translational case studies, including limitations and lessons learnedContributions that explicitly connect materials innovation with translational feasibility are particularly encouraged. Topic editors: Reza Mohammadinejad, Anna Chiara De Luca, Ilaria Rea Source: https://www.frontiersin.org/research-topics/78980/navigating-the-translational-chasm-advancing-nanoscale-materials-to-clinical-realization