Point-of-care production of therapeutic proteins of good-manufacturing-practice quality
Point-of-care production of therapeutic proteins of good-manufacturing-practice quality
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DOI：
10.1038/s41551-018-0259-1
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发表时间：
2018-09-01
影响因子：
28.1
通讯作者：
Zuber, Adil
中科院分区：
文献类型：
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作者：
Adiga, Rajani;Al-adhami, Mustafa;Zuber, Adil
生物制品的制造技术依赖于大型、集中、良好生产规范 (GMP) 生产设施和繁琐的产品分销网络。在此，我们报告了一种自动化便携式按需医疗设备的开发，该设备能够在数小时的时间内持续、小规模地按照 GMP 生产治疗级生物制剂。该装置将使用重组冻干中国仓鼠卵巢细胞的提取物从核糖体 DNA 中体外翻译目标蛋白，并持续纯化蛋白。我们使用该设备可重复地生产 His 标记的粒细胞集落刺激因子、促红细胞生成素、葡萄糖结合蛋白和白喉类毒素 DT5。按需用药技术可以实现在护理点快速生产生物制剂。
Manufacturing technologies for biologics rely on large, centralized, good-manufacturing-practice (GMP) production facilities and on a cumbersome product-distribution network. Here, we report the development of an automated and portable medicineson-demand device that enables consistent, small-scale GMP manufacturing of therapeutic-grade biologics on a timescale of hours. The device couples the in vitro translation of target proteins from ribosomal DNA, using extracts from reconstituted lyophilized Chinese hamster ovary cells, with the continuous purification of the proteins. We used the device to reproducibly manufacture His-tagged granulocyte-colony stimulating factor, erythropoietin, glucose-binding protein and diphtheria toxoid DT5. Medicines-on-demand technology may enable the rapid manufacturing of biologics at the point of care.