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

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.

Measurements of heterogeneity in proteomics analysis of the nanoparticle protein corona across core facilities

“…With continuously emerging applications of protein corona analysis in the assessment of NPs' safety and predicting their biological fate as well as biomarker discovery for disease detection, based on these data, as a community we need to pursue paths to minimize and report these differences so that we can better understand the underlying bias in proteomics data for protein corona experiments. This study can, therefore, serve as the first step in unifying and streamlining a standardized mass spectroscopy approach involving sample preparation protocols and instrumental settings for protein corona analysis 60 , similar to guidelines suggested for plasma proteomics 57 .…”

The Issue of Reliability and Repeatability of Analytical Measurement in Industrial and Academic Nanomedicine

“…The details and scope of these standards are beyond the scope of this perspective and are reported elsewhere. 6 Although these standards and guidelines are helpful, it is worth noting that nanomedicine is a very broad field. Each class of nanomaterials and each category of drug products (proteins, nucleic acids, small-molecule drugs) delivered by nanoparticles, as well as drug vs device fields, have their own unique set of distinctions and requirements.…”

“…These standards allow an organization to establish technical competence in using analytical instruments or nanomaterials testing to generate reliable and reproducible results. As part of these systems, many other standards such as nanomaterials characterization, toxicity evaluation, or use of instrumentation for specific nanomaterials may become applicable . Implementation of these quality management systems standards as well as specific standards includes establishing a quality assurance team that is independent of the organization’s research arm to verify and document compliance with standard rules, verify the maintenance and calibration of analytical instruments, verify the validation of analytical methods, document, and publish both positive and negative results as well as develop standard operating procedures.…”

“…One strategy that may improve the consistency and reproducibility in nanomedicine is to use standard methodological and characterization techniques for evaluations of nanomaterials and their interactions with biosystems. Details of these standards are available elsewhere …”

Nanomedicine-based commercial formulations: current developments and future prospects

“…However, realizing such at an industrial scale may be expensive and challenging (Jacquemart et al 2016 ). Furthermore, the complex nature of nanomedicine formulation and manufacturing requires close scrutiny to minimize batch-to-batch variations (Sharifi et al 2022 ). Therefore, for successful development and commercialization, it is necessary to ensure the purity, potency, safety, and efficacy of the nanomedicines (Desai 2012 ).…”