Importance of Standardizing Analytical Characterization Methodology for Improved Reliability of the Nanomedicine Literature

Understanding the interaction between biological structures and nanoscale technologies, dubbed the nano-bio interface, is required for successful development of safe and efficient nanomedicine products. The lack of a universal reporting system and decentralized methodologies for nanomaterial characterization have resulted in a low degree of reliability and reproducibility in the nanomedicine literature. As such, there is a strong need to establish a characterization system to support the reproducibility of nanoscience data particularly for studies seeking clinical translation. Here, we discuss the existing key standards for addressing robust characterization of nanomaterials based on their intended use in medical devices or as pharmaceuticals. We also discuss the challenges surrounding implementation of such standard protocols and their implication for translation of nanotechnology into clinical practice. We, however, emphasize that practical implementation of standard protocols in experimental laboratories requires long-term planning through integration of stakeholders including institutions and funding agencies.

Automated summary

Understanding the interaction between biological structures and nanoscale technologies is crucial for the development of safe and efficient nanomedicine products. However, the lack of a universal reporting system and standardized methods for nanomaterial characterization has resulted in low reliability and reproducibility in nanomedicine literature. It is necessary to establish a characterization system to support reproducibility of nanoscience data, especially for studies seeking clinical translation. Implementation of standard protocols in experimental laboratories requires long-term planning and collaboration among stakeholders.