Quantitative laser diffraction method for the assessment of protein subvisible particles

Totoki, Shinichiro; Yamamoto, Gaku; Tsumoto, Kouhei et al.

Journal of Pharmaceutical Sciences, 2015, 104(2), 618-626

Number of Access:570（2025-08-14 03:15 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/79033

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Title
Quantitative laser diffraction method for the assessment of protein subvisible particles
Creator
CreatorName
Totoki, Shinichiro
CreatorName
Yamamoto, Gaku
NRID
1000090271866 1000090271866
CreatorName
Tsumoto, Kouhei
NRID
1000090335381 1000090335381
ORCID
0000-0002-5181-179X 0000-0002-5181-179X
researchmap permalink
read0090387 read0090387
Scopus Author ID
35429790100 35429790100
CreatorName
Uchiyama, Susumu
NRID
1000000311770 1000000311770
researchmap permalink
read0068600 read0068600
CreatorName
Fukui, Kiichi
Subject
laser diffraction method
proteins
protein aggregation
biopharmaceutical characterization
subvisible particles
imaging methods
particle size
Description
Shinichiro Totoki, Gaku Yamamoto, Kouhei Tsumoto, Susumu Uchiyama, Kiichi Fukui. Quantitative Laser Diffraction Method for the Assessment of Protein Subvisible Particles. Journal of Pharmaceutical Sciences, Volume 104, Issue 2, 2015, Pages 618-626. https://doi.org/10.1002/jps.24288.
Abstract
Laser diffraction (LD) has been recognized as a method for estimating particle size distribution. Here, a recently developed quantitative LD (qLD) system, which is an LD method with extensive deconvolution analysis, was employed for the quantitative assessment of protein particles sizes, especially aimed at the quantification of 0.2-10 μm diameter subvisible particles (SVPs). The qLD accurately estimated concentration distributions for silica beads with diameters ranging from 0.2 to 10 μm that have refractive indices similar to that of protein particles. The linearity of concentration for micrometer-diameter silica beads was confirmed in the presence of a fixed concentration of submicrometer diameter beads. Similarly, submicrometer-diameter silica beads could be quantified in the presence of micrometer-diameter beads. Subsequently, stir- and heat-stressed intravenous immunoglobulins were evaluated by using the qLD, in which the refractive index of protein particles that was determined experimentally was used in the deconvolution analysis. The results showed that the concentration distributions of protein particles in SVP size range differ for the two stresses. The number concentration of the protein particles estimated using the qLD agreed well with that obtained using flow microscopy. This work demonstrates that qLD can be used for quantitative estimation of protein aggregates in SVP size range.
Publisher
Elsevier
Source Title
Journal of Pharmaceutical Sciences
Volume (Issue)
104(2)
Page
618-626
Date of Issued
2015-01-01
Language
English
Handle URL
https://hdl.handle.net/11094/79033
PISSN
00223549
eISSN
15206017
NCID
AA00704450
Relation.isIdenticalTo
DOI (Publisher Version)
https://doi.org/10.1002/jps.24288
PMID
25449441
Access Rights
open access
CopyRight
© 2014 The Authors. Journal of Pharmaceutical Sciences published by Wiley Periodicals, Inc. and the American Pharmacists Association. Published by Elsevier Inc. This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
oaire:version
Version of Record
Category
学術雑誌論文 Journal Article