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

ABSTRACTWithin 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.

• Publication year

  2010

• Venue

  Pharmaceutical Research

• Publication date

  2010-10-23

• Fields of study

  Biology, Medicine, Business

• Identifiers
  DOI 10.1007/s11095-010-0297-1PMID 20972611PMCID 3063870
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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