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

Rajani Adiga¹, Mustafa Al-Adhami^{1

2}, Abhay Andar¹, Shayan Borhani^{1

3}, Sheniqua Brown^{1

3}, David Burgenson^{1

3}, Merideth A Cooper⁴, Sevda Deldari^{1

3}, Douglas D Frey^{1

3}, Xudong Ge^{1

3}, Hui Guo^{1

3}, Chandrasekhar Gurramkonda¹, Penny Jensen⁵, Yordan Kostov^{1

3}, William LaCourse⁶, Yang Liu³, Antonio Moreira^{1

3}, KarunaSri Mupparapu¹, Chariz Peñalber-Johnstone¹, Manohar Pilli¹, Benjamin Punshon-Smith⁷, Aniruddha Rao^{1

6}, Govind Rao^{8

9}, Priyanka Rauniyar¹⁰, Sergei Snovida⁵, Kanika Taurani¹, Dagmawi Tilahun¹, Leah Tolosa^{1

3}, Michael Tolosa¹, Kevin Tran¹, Krishna Vattem⁵, Sudha Veeraraghavan^{11

12}, Brandon Wagner¹, Joshua Wilhide¹⁰, David W Wood⁴, Adil Zuber³

Affiliations

¹ Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, MD, USA.
² Department of Mechanical Engineering, University of Maryland Baltimore County, Baltimore, MD, USA.
³ Department of Chemical, Biochemical and Environmental Engineering, University of Maryland Baltimore County, Baltimore, MD, USA.
⁴ Department of Chemical and Biomolecular Engineering, Ohio State University, Columbus, OH, USA.
⁵ Protein Biology Bioscience Division, Thermo Fisher Scientific, Rockford, IL, USA.
⁶ Department of Biological Sciences, University of Maryland Baltimore County, Baltimore, MD, USA.
⁷ Department of Computer Science and Electrical Engineering, University of Maryland Baltimore County, Baltimore, MD, USA.
⁸ Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, MD, USA. grao@umbc.edu.
⁹ Department of Chemical, Biochemical and Environmental Engineering, University of Maryland Baltimore County, Baltimore, MD, USA. grao@umbc.edu.
¹⁰ Department of Chemistry and Biochemistry, University of Maryland Baltimore County, Baltimore, MD, USA.
¹¹ Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, USA.
¹² Center for Scientific Review, National Institutes of Health, Bethesda, MD, USA.

PMID: 31015674
DOI: 10.1038/s41551-018-0259-1

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

Rajani Adiga et al. Nat Biomed Eng. 2018 Sep.

. 2018 Sep;2(9):675-686.

doi: 10.1038/s41551-018-0259-1. Epub 2018 Jul 9.

Authors

Affiliations

¹ Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, MD, USA.
² Department of Mechanical Engineering, University of Maryland Baltimore County, Baltimore, MD, USA.
³ Department of Chemical, Biochemical and Environmental Engineering, University of Maryland Baltimore County, Baltimore, MD, USA.
⁴ Department of Chemical and Biomolecular Engineering, Ohio State University, Columbus, OH, USA.
⁵ Protein Biology Bioscience Division, Thermo Fisher Scientific, Rockford, IL, USA.
⁶ Department of Biological Sciences, University of Maryland Baltimore County, Baltimore, MD, USA.
⁷ Department of Computer Science and Electrical Engineering, University of Maryland Baltimore County, Baltimore, MD, USA.
⁸ Center for Advanced Sensor Technology, University of Maryland Baltimore County, Baltimore, MD, USA. grao@umbc.edu.
⁹ Department of Chemical, Biochemical and Environmental Engineering, University of Maryland Baltimore County, Baltimore, MD, USA. grao@umbc.edu.
¹⁰ Department of Chemistry and Biochemistry, University of Maryland Baltimore County, Baltimore, MD, USA.
¹¹ Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, USA.
¹² Center for Scientific Review, National Institutes of Health, Bethesda, MD, USA.

PMID: 31015674
DOI: 10.1038/s41551-018-0259-1

Abstract

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 medicines-on-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.

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

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

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