Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Apr;28(4):920-33.
doi: 10.1007/s11095-010-0297-1. Epub 2010 Oct 23.

Strategies for the assessment of protein aggregates in pharmaceutical biotech product development

John den Engelsman  1 , Patrick Garidel, Ronald Smulders, Hans Koll, Bryan Smith, Stefan Bassarab, Andreas Seidl, Otmar Hainzl, Wim Jiskoot
Affiliations

Strategies for the assessment of protein aggregates in pharmaceutical biotech product development

John den Engelsman et al. Pharm Res. 2011 Apr.

Abstract

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.

PubMed Disclaimer

References

    1. Hermeling S, Crommelin DJA, Schellekens H, Jiskoot W. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res. 2004;21:897–903. doi: 10.1023/B:PHAM.0000029275.41323.a6. - DOI - PubMed
    1. Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J. 2006;8(3):E501–7. doi: 10.1208/aapsj080359. - DOI - PMC - PubMed
    1. Chi EY, Krishnan S, Randolph TW, Carpenter JF. Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation. Pharm Res. 2003;20:1325–39. doi: 10.1023/A:1025771421906. - DOI - PubMed
    1. Mahler HC, Friess W, Grauschopf U, Kiese S. Protein aggregation: pathways, induction factors and analysis. J Pharm Sci. 2009;98:2909–34. doi: 10.1002/jps.21566. - DOI - PubMed
    1. Bhatnagar BS, Bogner RH, Pikal MJ. Protein stability during freezing: separation of stresses and mechanisms of protein stabilization. Pharm Dev Technol. 2007;12:505–23. doi: 10.1080/10837450701481157. - DOI - PubMed

MeSH terms

Substances