On-demand manufacturing of clinical-quality biopharmaceuticals
Name
nihms-1505042.pdf
Description
Accepted version
Size
2.05 MB
Format
Adobe PDF
Checksum (MD5)
d2d778103270ecfad644806819070e8a
Author(s)
Crowell, Laura E
Lu, Amos E
Love, Kerry R
Stockdale, Alan
Timmick, Steven M
Wu, Di
Wang, Yu Annie
Doherty, William
Bonnyman, Alexandra
Vecchiarello, Nicholas
Date Issued
2018
Journal
Nature Biotechnology
Publisher
Springer Science and Business Media LLC
Version
Author's final manuscript
Abstract
© 2018, Nature Publishing Group. All rights reserved. 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 purification1–4. 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 a-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.
MIT Department
Koch Institute for Integrative Cancer Research at MIT
Massachusetts Institute of Technology. Department of Chemical Engineering
Massachusetts Institute of Technology. Department of Mechanical Engineering
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Creative Commons Attribution-Noncommercial-Share Alike
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DOI of Published Version
10.1038/NBT.4262
