التفاصيل البيبلوغرافية
| العنوان: |
On-demand manufacturing of clinical-quality biopharmaceuticals |
| المؤلفون: |
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, Goodwine, Chaz, Bradbury, Lisa, Brady, Joseph R, Clark, John J, Colant, Noelle A, Cvetkovic, Aleksandar, Dalvie, Neil C, Liu, Diana, Liu, Yanjun, Mascarenhas, Craig A, Matthews, Catherine B, Mozdzierz, Nicholas J, Shah, Kartik A, Wu, Shiaw-Lin, Hancock, William S, Braatz, Richard D, Cramer, Steven M, Love, J Christopher |
| المساهمون: |
Koch Institute for Integrative Cancer Research at MIT, Massachusetts Institute of Technology. Department of Chemical Engineering, Massachusetts Institute of Technology. Department of Mechanical Engineering |
| المصدر: |
PMC |
| بيانات النشر: |
Springer Science and Business Media LLC |
| سنة النشر: |
2019 |
| المجموعة: |
DSpace@MIT (Massachusetts Institute of Technology) |
| الوصف: |
© 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. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| العلاقة: |
Nature Biotechnology; https://hdl.handle.net/1721.1/134719Test |
| الإتاحة: |
https://hdl.handle.net/1721.1/134719Test |
| حقوق: |
Creative Commons Attribution-Noncommercial-Share Alike ; http://creativecommons.org/licenses/by-nc-sa/4.0Test/ |
| رقم الانضمام: |
edsbas.DFA0EF68 |
| قاعدة البيانات: |
BASE |
