Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development

Within the European Immunogenicity Platform (EIP) (http://www.e-i-p.eu), the Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and exchange experience of protein characterization in relation to unwanted immunogenicity. In this commentary, we, as representatives of EIP-P...

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Autores principales: den Engelsman, John, Garidel, Patrick, Smulders, Ronald, Koll, Hans, Smith, Bryan, Bassarab, Stefan, Seidl, Andreas, Hainzl, Otmar, Jiskoot, Wim
Formato: Texto
Lenguaje:English
Publicado: Springer US 2010
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063870/
https://www.ncbi.nlm.nih.gov/pubmed/20972611
http://dx.doi.org/10.1007/s11095-010-0297-1
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author den Engelsman, John
Garidel, Patrick
Smulders, Ronald
Koll, Hans
Smith, Bryan
Bassarab, Stefan
Seidl, Andreas
Hainzl, Otmar
Jiskoot, Wim
author_facet den Engelsman, John
Garidel, Patrick
Smulders, Ronald
Koll, Hans
Smith, Bryan
Bassarab, Stefan
Seidl, Andreas
Hainzl, Otmar
Jiskoot, Wim
author_sort den Engelsman, John
collection PubMed
description Within the European Immunogenicity Platform (EIP) (http://www.e-i-p.eu), the Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and exchange experience of protein characterization in relation to unwanted immunogenicity. In this commentary, we, as representatives of EIP-PCS, review the current state of methods for analysis of protein aggregates. Moreover, we elaborate on why these methods should be used during product development and make recommendations to the biotech community with regard to strategies for their application during the development of protein therapeutics.
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spelling pubmed-30638702011-04-05 Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development den Engelsman, John Garidel, Patrick Smulders, Ronald Koll, Hans Smith, Bryan Bassarab, Stefan Seidl, Andreas Hainzl, Otmar Jiskoot, Wim Pharm Res Commentary Within the European Immunogenicity Platform (EIP) (http://www.e-i-p.eu), the Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and exchange experience of protein characterization in relation to unwanted immunogenicity. In this commentary, we, as representatives of EIP-PCS, review the current state of methods for analysis of protein aggregates. Moreover, we elaborate on why these methods should be used during product development and make recommendations to the biotech community with regard to strategies for their application during the development of protein therapeutics. Springer US 2010-10-23 2011 /pmc/articles/PMC3063870/ /pubmed/20972611 http://dx.doi.org/10.1007/s11095-010-0297-1 Text en © The Author(s) 2010 https://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.
spellingShingle Commentary
den Engelsman, John
Garidel, Patrick
Smulders, Ronald
Koll, Hans
Smith, Bryan
Bassarab, Stefan
Seidl, Andreas
Hainzl, Otmar
Jiskoot, Wim
Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
title Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
title_full Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
title_fullStr Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
title_full_unstemmed Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
title_short Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development
title_sort strategies for the assessment of protein aggregates in pharmaceutical biotech product development
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063870/
https://www.ncbi.nlm.nih.gov/pubmed/20972611
http://dx.doi.org/10.1007/s11095-010-0297-1
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