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.
Journal Articles:
- Point-of-care production of therapeutic proteins of good-manufacturing-practice quality, Nature Biomedical Engineering, volume 2, pages675–686 (2018)
- Making biologics on demand, Systems make flipping the switch on biopharmaceutical production faster and easier, potentially enabling personalized medicine by Celia Henry Arnaud NOVEMBER 12, 2018 | APPEARED IN VOLUME 96, ISSUE 45 https://cen.acs.org/biological-chemistry/biotechnology/Making-biologics-demand/96/i45
