Point-of-care production of therapeutic proteins of good-manufacturing-practice quality

被引：77

作者：

Adiga, Rajani ^{[1
]}

Al-adhami, Mustafa ^{[1
,2
]}

Andar, Abhay ^{[1
]}

Borhani, Shayan ^{[1
,3
]}

Brown, Sheniqua ^{[1
,3
]}

Burgenson, David ^{[1
,3
]}

Cooper, Merideth A. ^{[4
]}

Deldari, Sevda ^{[1
,3
]}

Frey, Douglas D. ^{[1
,3
]}

Ge, Xudong ^{[1
,3
]}

Guo, Hui ^{[1
,3
]}

Gurramkonda, Chandrasekhar ^{[1
]}

Jensen, Penny ^{[5
]}

Kostov, Yordan ^{[1
,3
]}

LaCourse, William ^{[6
]}

Liu, Yang ^{[3
]}

Moreira, Antonio ^{[1
,3
]}

Mupparapu, KarunaSri ^{[1
]}

Penalber-Johnstone, Chariz ^{[1
]}

Pilli, Manohar ^{[1
]}

Punshon-Smith, Benjamin ^{[7
]}

Rao, Aniruddha ^{[1
,6
]}

Rao, Govind ^{[1
,3
]}

Rauniyar, Priyanka ^{[8
]}

Snovida, Sergei ^{[5
]}

Taurani, Kanika ^{[1
]}

Tilahun, Dagmawi ^{[1
]}

Tolosa, Leah ^{[1
,3
]}

Tolosa, Michael ^{[1
]}

Tran, Kevin ^{[1
]}

Vattem, Krishna ^{[5
]}

Veeraraghavan, Sudha ^{[9
,10
]}

Wagner, Brandon ^{[1
]}

Wilhide, Joshua ^{[8
]}

Wood, David W. ^{[4
]}

Zuber, Adil ^{[3
]}

机构：

[1] Univ Maryland Baltimore Cty, Ctr Adv Sensor Technol, Baltimore, MD 21228 USA

[2] Univ Maryland Baltimore Cty, Dept Mech Engn, Baltimore, MD 21228 USA

[3] Univ Maryland Baltimore Cty, Dept Chem Biochem & Environm Engn, Baltimore, MD 21228 USA

[4] Ohio State Univ, Dept Chem & Biomol Engn, Columbus, OH 43210 USA

[5] Thermo Fisher Sci, Prot Biol Biosci Div, Rockford, IL USA

[6] Univ Maryland Baltimore Cty, Dept Biol Sci, Baltimore, MD 21228 USA

[7] Univ Maryland Baltimore Cty, Dept Comp Sci & Elect Engn, Baltimore, MD 21228 USA

[8] Univ Maryland Baltimore Cty, Dept Chem & Biochem, Baltimore, MD 21228 USA

[9] Univ Maryland, Sch Pharm, Dept Pharmaceut Sci, Baltimore, MD 21201 USA

[10] NIH, Ctr Sci Review, Bldg 10, Bethesda, MD 20892 USA

来源：

NATURE BIOMEDICAL ENGINEERING | 2018年 / 2卷 / 09期

关键词：

CELL; EXPRESSION; BIOLOGY; SYSTEM;

D O I：

10.1038/s41551-018-0259-1

中图分类号：

R318 [生物医学工程];

学科分类号：

0831 ;

摘要：

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.

引用

页码：675 / 686

页数：12

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