表征治疗性重组糖蛋白的糖基化状态。

Characterizing the glycosylation state of therapeutic recombinant glycoproteins.

作者信息

Samuels Nicole, Kates David, Liu Jun, Severs Joanne

机构信息

Analytical Development and Support, Global Biological Development, Bayer Healthcare LLC, Berkeley, CA, USA.

出版信息

Methods Mol Biol. 2013;951:323-34. doi: 10.1007/978-1-62703-146-2_22.

DOI:10.1007/978-1-62703-146-2_22

PMID:23296541

Abstract

As an increasing number of recombinant therapeutic glycoproteins are manufactured and investigated, the importance of their attached glycans is becoming more widely reported and understood. Regulatory agencies expect detailed "extended characterization" of the glycoprotein as well as routine, well-controlled "release assays" with specifications to be employed for quality control of each manufactured lot. In this chapter we will briefly discuss relevant glycan issues in the area of therapeutic recombinant glycoprotein manufacture and describe in detail two assays that are employed in the development of, for example, recombinant Factor VIII for the treatment of hemophilia.

摘要

随着越来越多的重组治疗性糖蛋白被生产和研究，其连接聚糖的重要性得到了更广泛的报道和理解。监管机构期望对糖蛋白进行详细的“扩展表征”，以及采用常规的、严格控制的“放行检测”并制定规格，以对每一批生产产品进行质量控制。在本章中，我们将简要讨论治疗性重组糖蛋白生产领域中的相关聚糖问题，并详细描述在例如用于治疗血友病的重组凝血因子VIII的研发过程中所采用的两种检测方法。