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标题：The Significance of Glycosylation Analysis in Development of Biopharmaceuticals
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作者：Nana Kawasaki ; Satsuki Itoh ; Noritaka Hashii 等
期刊名称：Biological and Pharmaceutical Bulletin
印刷版ISSN：0918-6158
电子版ISSN：1347-5215
出版年度：2009
卷号：32
期号：5
页码：796-800
DOI：10.1248/bpb.32.796
出版社：The Pharmaceutical Society of Japan
摘要：Many glycoproteins and glycosaminoglycans are approved for clinical use. Carbohydrate moieties in biopharmaceuticals affect not only their physicochemical properties and thermal stability, but also their reactivity with their receptors and circulating half-life. Modification of glycans is one target of drug design for enhancement of efficacy. Meanwhile, there have been reports of serious adverse events caused by some carbohydrates. It is crucial to maintain the constancy of carbohydrate moieties for the efficient and safe use of glycosylated biopharmaceuticals. On the other hand, for scientific, safety-related, and economic reasons, changes in the manufacturing process are frequently made either during the development or after the approval of new biopharmaceuticals. Furthermore, the development of biosimilar glycoprotein products has been attempted by different manufacturers. Changes in pharmaceutical manufacturing processes possibly cause alteration of glycosylation and raise concerns about alteration of their quality, safety, and efficacy. In this review we provide some current topics of glycosylated biopharmaceuticals from the viewpoints of efficacy, safety, and the manufacturing process and discuss the significance of glycosylation analysis for development of biopharmaceuticals.
关键词：glycoprotein;glycosaminoglycan;biopharmaceutical;efficacy;safety;manufacturing process