Critical Evaluation of Microfluidic Resistive Pulse Sensing for Quantification and Sizing of Nanometer- and Micrometer-Sized Particles in Biopharmaceutical Products
Critical Evaluation of Microfluidic Resistive Pulse Sensing for Quantification and Sizing of Nanometer- and Micrometer-Sized Particles in Biopharmaceutical Products
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DOI：
10.1016/j.xphs.2018.08.020
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发表时间：
2019-01-01
影响因子：
3.8
通讯作者：
Hawe, Andrea
中科院分区：
文献类型：
--
作者：
Grabarek, Adam D.;Weinbuch, Daniel;Hawe, Andrea
目的是评估微流控电阻脉冲传感（MRPS）技术的性能、优势和局限性，用于表征尺寸范围从50到2000纳米的颗粒。比较了MRPS、共振质量测量（RMM）、纳米颗粒跟踪分析（NTA）和动态光散射技术对纳米聚苯乙烯（PS）微珠、脂质体、细菌和蛋白质聚集体的分析。电导率至少为3 mS/cm（相当于25 mM NaCl）被确定为MRPS可靠分析的关键要求。MRPS、NTA和RMM测定的PS珠粒粒径分布相关性较好。然而，不同技术的计数精度差异很大，RMM的计数精度最好，其次是MRPS和NTA。通过测量单穗和混合穗群体，MRPS显示出最高的施胶峰值分辨率。相对于动态光散射和NTA， RMM和MRPS是表征应力蛋白样品的最佳方法。最后，MRPS被证明是唯一能够同时表征细菌和脂质体的分析技术。总之，MRPS是一种正交技术，与其他已建立的技术一起，用于样品粒度分布和颗粒浓度的综合分析。(C) 2019年美国药剂师协会(R)。Elsevier Inc.出版。版权所有。
The objective was to evaluate performance, strengths, and limitations of the microfluidic resistive pulse sensing (MRPS) technique for the characterization of particles in the size range from about 50 to 2000 nm. MRPS, resonant mass measurement (RMM), nanoparticle tracking analysis (NTA) and dynamic light scattering were compared for the analysis of nanometer-sized polystyrene (PS) beads, liposomes, bacteria, and protein aggregates. An electrical conductivity of at least 3 mS/cm (equivalent to 25 mM NaCl) was determined as a key requirement for reliable analysis with MRPS. Particle size distributions of PS beads determined by MRPS, NTA, and RMM correlated well. However, counting precision varied significantly among the techniques and was best for RMM followed by MRPS and NTA. As determined by measuring single and mixed PS bead populations, MRPS showed the highest peak resolution for sizing. RMM and MRPS were superior over dynamic light scattering and NTA for the characterization of stressed protein samples. Finally, MRPS proved to be the only analytical technique able to characterize both bacteria and liposomes. In conclusion, MRPS is an orthogonal technique alongside other established techniques for a comprehensive analysis of a samples particle size distribution and particle concentration. (C) 2019 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.