Biotech pharmaceuticals and biotherapy: an overview.
Biotech pharmaceuticals and biotherapy: an overview.
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生物技术药物和生物治疗：概述。
DOI：
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发表时间：
1998
影响因子：
2.7
通讯作者：
J. Raso
中科院分区：
文献类型：
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作者：
F. Steinberg;J. Raso
从广义上讲，制药生物技术的历史包括1928年亚历山大弗莱明在一种常见的霉菌中发现青霉素，以及随后在第二次世界大战受伤的推动下，在肉汤罐中培养有机体的大规模生产方法的发展。制药生物技术从此发生了巨大的变化。20世纪70年代末的两项突破成为现代生物技术产业的基础：遗传物质的物种间移植以及肿瘤细胞和某些白细胞的融合。由这种融合杂交瘤产生的细胞不断复制，可以大量生产特异性抗体。现代制药生物技术包括基因克隆和重组DNA技术。基因克隆包括分离对应于单个基因的DNA分子区段并合成（“复制”）该区段。重组DNA技术，或基因拼接，包括改变生物体外部的遗传物质--例如，通过将来自非常不同的DNA分子的片段插入DNA分子中--并使改变的物质（重组DNA）在生物中发挥作用。重组DNA技术能够修饰微生物、动物和植物，使它们产生医学上有用的物质，特别是稀缺的人类蛋白质（例如，通过赋予动物人类基因）。然而，这篇综述的重点不是药物生物技术的方法，而是其产品，特别是重组药物。它描述了各种类型的生物技术药物，它们的安全性和有效性相对于传统生产的药物的安全性和有效性，以及生物技术药物的监管。
Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming"s discovery of penicillin in a common mold, in 1928, and the subsequent development-prompted by World War II injuries-of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. The cells resulting from such fusion-hybridomas-replicate endlessly and can be geared to produce specific antibodies in bulk. Modern pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Gene cloning comprises isolating a DNA-molecule segment that corresponds to a single gene and synthesizing ("copying") the segment. Recombinant DNA technology, or gene splicing, comprises altering genetic material outside an organism-for example, by inserting into a DNA molecule a segment from a very different DNA molecule-and making the altered material (recombinant DNA) function in living things. Recombinant DNA technology enables modifying microorganisms, animals, and plants so that they yield medically useful substances, particularly scarce human proteins (by giving animals human genes, for example). This review, however, focuses not on pharmaceutical biotechnology"s methods but on its products, notably recombinant pharmaceuticals. It describes various types of biotech pharmaceuticals, their safety and effectiveness relative to the safety and effectiveness of conventionally produced pharmaceuticals, and the regulation of biotech pharmaceuticals.