在药物生物技术产品开发中评估蛋白质聚集体的策略。
Strategies for the assessment of protein aggregates in pharmaceutical biotech product development.
机构信息
Biological and Sterile Product Development, MSD, Oss, The Netherlands.
出版信息
Pharm Res. 2011 Apr;28(4):920-33. doi: 10.1007/s11095-010-0297-1. Epub 2010 Oct 23.
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.
摘要
在欧洲免疫原性平台（EIP）（http://www.e-i-p.eu）内，已经成立了蛋白质特性小组委员会（EIP-PCS），以讨论和交流与非预期免疫原性相关的蛋白质特性分析经验。在这篇评论中，我们作为 EIP-PCS 的代表，回顾了目前用于分析蛋白质聚集物的方法现状。此外，我们详细阐述了为什么在产品开发过程中应该使用这些方法，并向生物技术界就蛋白质治疗药物开发过程中应用这些方法的策略提出了建议。
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