Test models for the evaluation of immunogenicity of protein aggregates.


Journal

International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127

Informations de publication

Date de publication:
25 Mar 2019
Historique:
received: 20 11 2018
revised: 08 01 2019
accepted: 09 01 2019
pubmed: 22 1 2019
medline: 14 6 2019
entrez: 22 1 2019
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 30665000
pii: S0378-5173(19)30049-3
doi: 10.1016/j.ijpharm.2019.01.015
pii:
doi:

Substances chimiques

Protein Aggregates 0
Proteins 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

192-200

Informations de copyright

Copyright © 2019 Elsevier B.V. All rights reserved.

Auteurs

Teresa Kraus (T)

Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-Universität München, Butenandtstr. 5, D-81377 Munich, Germany. Electronic address: teresa.kraus@cup.uni-muenchen.de.

Gerhard Winter (G)

Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-Universität München, Butenandtstr. 5, D-81377 Munich, Germany.

Julia Engert (J)

Department of Pharmacy, Pharmaceutical Technology & Biopharmaceutics, Ludwig-Maximilians-Universität München, Butenandtstr. 5, D-81377 Munich, Germany.

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Classifications MeSH