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

Nat Biomed Eng. 2018 Sep;2(9):675-686. doi: 10.1038/s41551-018-0259-1. Epub 2018 Jul 9.

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.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Animals
  • Biological Products / chemistry*
  • CHO Cells
  • Cell Line
  • Cricetulus
  • DNA, Ribosomal / chemistry
  • Erythropoietin / chemistry
  • Granulocyte Colony-Stimulating Factor / chemistry
  • Humans
  • Point-of-Care Systems
  • Proteins / chemistry*

Substances

  • Biological Products
  • DNA, Ribosomal
  • Proteins
  • Erythropoietin
  • Granulocyte Colony-Stimulating Factor