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

Shahriar Sharifi; Nouf N Mahmoud; Elizabeth Voke; Markita P Landry; Morteza Mahmoudi

doi:10.1007/s40820-022-00922-5

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

Nanomicro Lett. 2022 Aug 20;14(1):172. doi: 10.1007/s40820-022-00922-5.

Authors

Shahriar Sharifi^#¹, Nouf N Mahmoud^#^{1

2

3}, Elizabeth Voke⁴, Markita P Landry^{5

6

7

8}, Morteza Mahmoudi⁹

Affiliations

¹ Department of Radiology and Precision Health Program, Michigan State University, East Lansing, MI, USA.
² Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, 11733, Jordan.
³ Department of Biomedical Sciences, College of Health Sciences, QU Health, Qatar University, 2713, Doha, Qatar.
⁴ Department of Chemical and Biomolecular Engineering, University of California, Berkeley, Berkeley, CA, USA.
⁵ Department of Chemical and Biomolecular Engineering, University of California, Berkeley, Berkeley, CA, USA. landry@berkeley.edu.
⁶ Innovative Genomics Institute, Berkeley, CA, USA. landry@berkeley.edu.
⁷ California Institute for Quantitative Biosciences, University of California, Berkeley, CA, USA. landry@berkeley.edu.
⁸ Chan Zuckerberg Biohub, San Francisco, CA, USA. landry@berkeley.edu.
⁹ Department of Radiology and Precision Health Program, Michigan State University, East Lansing, MI, USA. mahmou22@msu.edu.

^# Contributed equally.

Abstract

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.

Keywords: Characterization; Nanomedicine; Nanomedicine devices; Reproducibility; Standard protocols.

Grants and funding

R01 DK131417/DK/NIDDK NIH HHS/United States