Bioequivalence and the immunogenicity of biopharmaceuticals

被引:394
作者
Schellekens, H [1 ]
机构
[1] Univ Utrecht, Cent Lab, Dept Innovat Studies, Anim Inst, NL-3508 TD Utrecht, Netherlands
关键词
D O I
10.1038/nrd818
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
The expiry of the first patents for recombinant-DNA-derived biopharmaceuticals will open the possibility of marketing generics, if they can be shown to be essentially similar to the innovator product. However, as shown by the problem of immunogenicity, the properties of biopharmaceuticals are dependent on many factors, including downstream processing and formulation. Products from different sources cannot be assumed to be bioequivalent, even if identical genes are expressed in the same host cells and similar production methods are used. Some of the influencing factors are still unknown, which makes it impossible to completely predict biological behaviour, such as immunogenicity, which can sometimes lead to serious side effects.
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页码:457 / 462
页数:6
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