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Formation of protein sub-visible particles during vacuum degassing of etanercept solutions.

Abstract：

:The main purpose of this manuscript is to describe a phenomenon in which vacuum degassing a reconstituted freeze-dried fusion protein etanercept formulation caused a significant amount of protein sub-visible particles (SbVP). Physical stability of etanercept was monitored by micro-flow imaging (MFI), dynamic light scattering (DLS), size-exclusion high pressure liquid chromatography (SE-HPLC) and far- and near-ultraviolet circular dichroism (far- and near-UV CD). One potential explanation of this phenomenon is that bubble collapses when the vacuum is applied, leads to substantial heat formation, and ultimately free radical formation. Subsequently, the effect of a free-radical scavenger (ascorbic acid, AA) on SbVP formation was also evaluated. Degassing of etanercept solution by applying vacuum caused substantial increase of SbVP, as detected by MFI and DLS. However, traditional techniques such as SE-HPLC could not detect any change. The addition of free-radical scavenger had minimal effect on SbVP formation, therefore the formation of free radicals was probably not the main cause for this effect.

journal_name

Int J Biol Macromol

journal_title

International journal of biological macromolecules

authors

Wang H,Zheng HJ,Wang Z,Bai H,Carpenter JF,Chen S,Fang WJ

doi

10.1016/j.ijbiomac.2014.02.001

subject

Has Abstract

pub_date

2014-05-01 00:00:00

pages

151-7

eissn

0141-8130

issn

1879-0003

pii

S0141-8130(14)00074-9

journal_volume

66

pub_type

杂志文章

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