Varenne F, Rustique E, Botton J, Coty J-B, Lanusse G, Ait Lahcen M, Rio L, Zandanel C, Lemarchand C, Germain M, Negri L, Couffin A-C, Barratt G, Vauthier C
Institut Galien Paris-Sud, CNRS, Univ. Paris-Sud, University Paris-Saclay, Châtenay-Malabry, France.
University Grenoble Alpes, 34054 Grenoble, France; CEA, LETI, MINATEC Campus, 34054 Grenoble, France.
Int J Pharm. 2017 Aug 7;528(1-2):299-311. doi: 10.1016/j.ijpharm.2017.06.006. Epub 2017 Jun 22.
Quality control analysis of nanomaterials has been identified as a major issue to pursue their development in different industrial fields including nanomedicine. One difficulty is the lack of standardized and validated protocols suitable to achieve their characterization. In a previous work, we have developed standardized protocols for the evaluation of the size and zeta potential of nanomaterials based on methods described in the ISO standard and have performed validation of each one. The present work was aimed to transfer these protocols in three independent receiving laboratories. No official guideline was described in the literature to achieve such a transfer. A comparative study for receiving laboratories equipped with the same instrument as the sending laboratory was designed based on the Code of Federal Regulation edited by the Food and Drug Administration. For the receiving laboratory equipped with an instrument working at a different wavelength, a new validation was designed and applied. Corresponding statistical methods were used for the analysis of the results. A successful transfer of the protocols in all receiving laboratories was achieved. All laboratories recorded consistent results applying in blind the protocol of size measurements on two samples of nanomaterials from which included one reference.
纳米材料的质量控制分析已被视为推动其在包括纳米医学在内的不同工业领域发展的一个主要问题。其中一个困难是缺乏适用于对其进行表征的标准化且经过验证的方案。在之前的一项工作中，我们基于ISO标准中描述的方法，开发了用于评估纳米材料尺寸和zeta电位的标准化方案，并对每个方案进行了验证。目前的工作旨在将这些方案转移到三个独立的接收实验室。文献中未描述实现这种转移的官方指南。基于美国食品药品监督管理局编辑的联邦法规代码，为配备与发送实验室相同仪器的接收实验室设计了一项比较研究。对于配备工作波长不同仪器的接收实验室，设计并应用了新的验证方法。使用相应的统计方法对结果进行分析。在所有接收实验室中成功实现了方案的转移。所有实验室在对两种纳米材料样品（其中包括一个参考样品）进行尺寸测量方案的盲法应用中都记录了一致的结果。
