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Test models for the evaluation of immunogenicity of protein aggregates.

Abstract：

:Protein aggregates have been discussed for a long time as a potential risk factor for immunogenicity in patients. Meanwhile, many research groups have investigated the immunogenicity of differently produced aggregates using in vitro or in vivo models. Despite all knowledge gained in these studies still little is known about the mechanisms of immunogenicity and the kind of protein aggregates bearing the greatest risk for immunogenicity. The choice of a suitable test model regarding the predictability of immunogenicity of protein aggregates in humans plays a major role and influences results and conclusions substantially. In this review we will provide an overview of the test models recently used for the evaluation of immunogenicity of protein aggregates; we will discuss advantages and drawbacks regarding their usability and predictive power for immunogenicity in humans.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Kraus T,Winter G,Engert J

doi

10.1016/j.ijpharm.2019.01.015

subject

Has Abstract

pub_date

2019-03-25 00:00:00

pages

192-200

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(19)30049-3

journal_volume

559

pub_type

杂志文章,评审

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