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蛋白质类药物的稳定性:最新进展。

Stability of protein pharmaceuticals: an update.

机构信息

Legacy BioDesign LLC, Johnstown, Colorado 80534, USA.

出版信息

Pharm Res. 2010 Apr;27(4):544-75. doi: 10.1007/s11095-009-0045-6. Epub 2010 Feb 9.

DOI:10.1007/s11095-009-0045-6
PMID:20143256
Abstract

In 1989, Manning, Patel, and Borchardt wrote a review of protein stability (Manning et al., Pharm. Res. 6:903-918, 1989), which has been widely referenced ever since. At the time, recombinant protein therapy was still in its infancy. This review summarizes the advances that have been made since then regarding protein stabilization and formulation. In addition to a discussion of the current understanding of chemical and physical instability, sections are included on stabilization in aqueous solution and the dried state, the use of chemical modification and mutagenesis to improve stability, and the interrelationship between chemical and physical instability.

摘要

1989 年,曼宁、帕特尔和博查特(Manning et al.,Pharm. Res. 6:903-918, 1989)撰写了一篇关于蛋白质稳定性的综述,此后该综述被广泛引用。当时,重组蛋白治疗仍处于起步阶段。这篇综述总结了自那时以来在蛋白质稳定和配方方面取得的进展。除了讨论化学和物理不稳定性的当前理解外,还包括在水溶液和干燥状态下的稳定化、化学修饰和诱变以提高稳定性的应用,以及化学和物理不稳定性之间的相互关系。

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Aggregation of a monoclonal antibody induced by adsorption to stainless steel.单克隆抗体因吸附到不锈钢上而聚集。
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Tungsten-induced protein aggregation: solution behavior.钨诱导的蛋白质聚集:溶液行为。
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