Betaseron。
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Betaseron。
Dev杂志。1998;96:97 - 104。
- PubMed ID
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9890522 (在PubMed]
- 文摘
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Betaseron,模拟人类β干扰素丝氨酸是转基因代替半胱氨酸在位置17日在大肠杆菌。165年是一个小分子多肽的氨基酸与单个二硫化物键,non-glycosylated。站点特定的替换是获得产品贮存时更稳定。类似于本机IFN-beta, Betaseron在本质上是疏水的,已被证明有相同的面板的生物活动,包括对各种病毒的抗病毒活性,抑制细胞生长,激活自然杀伤细胞,绑定到干扰素受体在细胞表面。Betaseron已经测试了自1983年以来,在各种各样的临床设置。治疗复发缓和多发性硬化的关键试验始于1988年。1992年解放军申请这个指示Berlex和凯龙星,FDA批准于1993年获得。Betaseron在大肠杆菌合成和沉积为包涵体。的制造过程包括溶解和减少不溶性蛋白质,紧随其后的是由有机萃取净化,胱氨酸氧化和尺寸排除色谱步骤。人血清白蛋白的纯化Betaseron制定维护溶解在中性ph的完成主要序列Betaseron被氨基和carboxy-terminal序列分析证实,肽映射,氨基酸分析和片段分析后化学分裂。 Overlapping amino acid sequence information confirmed that the amino acid sequence is the same as predicted by the DNA sequence. The amino-terminal methionine of Betaseron is removed after synthesis in E. coli. An intramolecular disulphide bond between Cys 31 and Cys 141 formed during the manufacturing process is routinely confirmed by peptide map analysis. The purity of Betaseron is assessed using a panel of analytical methods including non-reducing and reducing SDS-PAGE and reversed phase HPLC analysis where minor product-related components can be identified. These minor species were characterized with respect to their biological and biochemical properties, and identified using a variety of approaches including construction of additional, beta-interferon analogs. There is significant redundancy in the release testing of Betaseron. The amount of characterization information available on this relatively simple molecule along with the extensive manufacturing experience would suggest that some redundant testing could be eliminated for this well-characterized protein.
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