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A snapshot of biologic drug development: Challenges and opportunities

机译:生物药物发展的快照:挑战和机遇

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Since the approval of insulin as the first recombinant therapeutic protein, the prominence of biologic therapies in drug development has grown significantly. Many modalities beyond traditional biologics are now being developed or explored for various indications with significant unmet medical needs. From early traditional replacement proteins to more recent, highly engineered antibodies, oligonucleotides, fusion proteins, and gene constructs, biologic agents have delivered life-changing therapies, despite often having scientifically and technically challenging development programs. This brief review outlines some of the major biotherapeutic classes and identifies the advantages and challenges with the development of these products.
机译:自胰岛素作为第一重组治疗蛋白的批准以来,生物疗法在药物发育中的突出显着增加。 现在正在开发或探索超出传统生物制剂的许多方式,以实现具有重大未满足医疗需求的各种适应症。 从早期的传统替代蛋白到更近期的,高度工程化的抗体,寡核苷酸,融合蛋白和基因构建体,尽管经常在科学和技术上挑战性的发展计划,但生物制剂已经递送了改变的疗效。 本文简介概述了一些主要的生物治疗课程,并确定了这些产品的发展的优缺点。

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