Useful resources

Reference Materials for Nanomedicine

  • Not an expert? Here's a summary for you: "Reference Materials in a Nutshell"
Think of reference materials as the 'gold standard' samples used in measurement science. They help scientists and manufacturers to check their work. If you're creating a new nanomedicine, you can use these reference materials to make sure your measurements are accurate. It's like having an answer key for a test, ensuring that your results are correct and trustworthy. For nanomedicines, this is particularly crucial because they are far more complex than traditional drugs. Their tiny size and sophisticated mechanisms of action require precise and highly specialized measurement techniques to ensure safety and efficacy. Reference materials in this field play a pivotal role in navigating these complexities, offering a reliable benchmark for the development and quality control of these advanced therapeutic products.

Reference materials are ‘material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process’.

ISO 17034:2016 General requirements for the competence of reference material producers.

Reference materials are designed and intended for method development, inter-laboratory comparisons, verification of instrument performances, or quality control.

Fit-for-purpose reference materials, specifically representing nanomedicine clinical formulations available in the market, are a significant advancement in establishing robust standards for the nanomedicine industry.

The Canadian Metrology institute, NRC has recently issued certificates of analysis for two reference materials, certified for their particle sizes, which are the first two reference materials specifically representing clinical drug products based on nanomedicine formulations.

METRINO is working to provide complementary reference materials to the community.

  • Where to find useful reference materials?
1. Nanomedicine-based formulation (Lipid-based nanoparticles reference materials):
2. Reference standards for medicinal products (EDQM):

The EDQM supplies chemical reference substances (CRS), herbal reference standards (HRS) and biological reference preparations (BRP) as well as reference spectra for the tests and assays to be carried out in accordance with the official methods prescribed in the European Pharmacopoeia. For more information consult the following links:

3. Databases of Nanotechnology-based reference standards:

For more information, consult the site of the NanoMeasureFrance association

 

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The METRINO project has received funding from the European Partnership on Metrology (Grant #22HLT04), co-financed from the European Union’s Horizon Europe Research and Innovation Programme and by the Participating States. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or EURAMET. Neither the European Union nor the granting authority can be held responsible for them.

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