Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.
Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars.
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DOI：
10.1038/nrd3746
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发表时间：
2012-06-29
影响因子：
120.1
通讯作者：
Jones, Graham B.
中科院分区：
文献类型：
--
作者：
Berkowitz, Steven A.;Engen, John R.;Mazzeo, Jeffrey R.;Jones, Graham B.
单克隆抗体等生物制剂比小分子药物复杂得多，这对此类生物制药产品（也称为生物仿制药）后续版本的开发和监管评估及其在开创性生物制剂的专利保护到期后的临床使用提出了具有挑战性的问题。随着最近引入复杂生物制剂后续版本的监管途径，分析技术在生物仿制药与相应参考产品比较中的作用引起了人们对建立生物仿制药开发要求的浓厚兴趣。在这里，我们讨论了分析技术的最新发展水平，以评估监管机构认为对生物仿制药开发策略很重要的蛋白质生物制药的三个特征：翻译后修饰、三维结构和蛋白质聚集。
Biologics such as monoclonal antibodies are much more complex than small-molecule drugs, which raises challenging questions for the development and regulatory evaluation of follow-on versions of such biopharmaceutical products (also known as biosimilars) and their clinical use once patent protection for the pioneering biologic has expired. With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the corresponding reference product is attracting substantial interest in establishing the development requirements for biosimilars. Here, we discuss the current state of the art in analytical technologies to assess three characteristics of protein biopharmaceuticals that regulatory authorities have identified as being important in development strategies for biosimilars: post-translational modifications, three-dimensional structures and protein aggregation.
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影响因子：
7.4
作者：
Bagal, Dhanashri;Zhang, Heidi;Schnier, Paul D.
通讯作者：
Schnier, Paul D.
影响因子：
3.5
作者：
Cao, Xiaolin;Wen, Zai-Qing;Torraca, Gianpiero
通讯作者：
Torraca, Gianpiero
影响因子：
3.4
作者：
Chalmers MJ;Busby SA;Pascal BD;West GM;Griffin PR
通讯作者：
Griffin PR
影响因子：
7.4
作者：
Atmanene, Cedric;Wagner-Rousset, Elsa;Sanglier-Cianferani, Sarah
通讯作者：
Sanglier-Cianferani, Sarah
影响因子：
3.8
作者：
Arthur, Kelly K.;Gabrielson, John P.;Stoner, Michael R.
通讯作者：
Stoner, Michael R.