Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins

Krayukhina, Elena; Tsumoto, Kouhei; Uchiyama, Susumu et al.

Journal of Pharmaceutical Sciences, 2015, 104(2), 527-535

Number of Access:563（2025-08-14 15:05 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/79032

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Title
Effects of syringe material and silicone oil lubrication on the stability of pharmaceutical proteins
Creator
CreatorName
Krayukhina, Elena
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
protein aggregation
prefilled syringe
physical stability
silicone oil
biopharmaceuticals characterization
subvisible particles
HPLC (high-performance/pressure liquid chromatography)
analytical ultracentrifugation
UV/Vis spectroscopy
Imaging methods
Description
Elena Krayukhina, Kouhei Tsumoto, Susumu Uchiyama, Kiichi Fukui. Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins. Journal of Pharmaceutical Sciences, Volume 104, Issue 2, 2015, Pages 527-535. ttps://doi.org/10.1002/jps.24184.
Abstract
Currently, polymer-based prefillable syringes are being promoted to the pharmaceutical market because they provide an increased break resistance relative to traditionally used glass syringes. Despite this significant advantage, the possibility that barrel material can affect the oligomeric state of the protein drug exists. The present study was designed to compare the effect of different syringe materials and silicone oil lubrication on the protein aggregation. The stability of a recombinant fusion protein, abatacept (Orencia), and a fully human recombinant immunoglobulin G1, adalimumab (Humira), was assessed in silicone oil-free (SOF) and silicone oil-lubricated 1-mL glass syringes and polymer-based syringes in accelerated stress study. Samples were subjected to agitation stress, and soluble aggregate levels were evaluated by size-exclusion chromatography and verified with analytical ultracentrifugation. In accordance with current regulatory expectations, the amounts of subvisible particles resulting from agitation stress were estimated using resonant mass measurement and dynamic flow-imaging analyses. The amount of aggregated protein and particle counts were similar between unlubricated polymer-based and glass syringes. The most significant protein loss was observed for lubricated glass syringes. These results suggest that newly developed SOF polymer-based syringes are capable of providing biopharmaceuticals with enhanced physical stability upon shipping and handling.
Publisher
Elsevier
Source Title
Journal of Pharmaceutical Sciences
Volume (Issue)
104(2)
Page
527-535
Date of Issued
2015-02-01
Language
English
Handle URL
https://hdl.handle.net/11094/79032
PISSN
00223549
eISSN
15206017
NCID
AA00704450
Relation.isIdenticalTo
DOI (Publisher Version)
https://doi.org/10.1002/jps.24184
PMID
25256796
Access Rights
open access
CopyRight
© 2015 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 4.0 International License.
oaire:version
Version of Record
Category
学術雑誌論文 Journal Article