Crowell, LE;
Lu, AE;
Love, KR;
Stockdale, A;
Timmick, SM;
Wu, D;
Wang, YA;
... Love, JC; + view all
(2018)
On-demand manufacturing of clinical-quality biopharmaceuticals.
[Letter].
Nature Biotechnology
, 36
(10)
pp. 988-995.
10.1038/nbt.4262.
Preview |
Text
Colant_On-demand manufacturing of clinical-quality biopharmaceuticals_AAM.pdf - Accepted Version Download (2MB) | Preview |
Abstract
Conventional manufacturing of protein biopharmaceuticals in centralized, large-scale, single-product facilities is not well-suited to the agile production of drugs for small patient populations or individuals. Previous solutions for small-scale manufacturing are limited in both process reproducibility and product quality, owing to their complicated means of protein expression and purification. We describe an automated, benchtop, multiproduct manufacturing system, called Integrated Scalable Cyto-Technology (InSCyT), for the end-to-end production of hundreds to thousands of doses of clinical-quality protein biologics in about 3 d. Unlike previous systems, InSCyT includes fully integrated modules for sustained production, efficient purification without the use of affinity tags, and formulation to a final dosage form of recombinant biopharmaceuticals. We demonstrate that InSCyT can accelerate process development from sequence to purified drug in 12 weeks. We used integrated design to produce human growth hormone, interferon α-2b and granulocyte colony-stimulating factor with highly similar processes on this system and show that their purity and potency are comparable to those of marketed reference products.
| Type: | Article |
|---|---|
| Title: | On-demand manufacturing of clinical-quality biopharmaceuticals |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1038/nbt.4262 |
| Publisher version: | https://doi.org/10.1038/nbt.4262 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Biologics, Recombinant protein therapy |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Chemical Engineering |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10076060 |
Archive Staff Only
 |
View Item |
