The design basis for the integrated and continuous biomanufacturing framework.
biopharmaceutical
dual-column chromatography
integrated continuous bioprocessing
mammalian cells
perfusion
protein therapeutics
Journal
Biotechnology and bioengineering
ISSN: 1097-0290
Titre abrégé: Biotechnol Bioeng
Pays: United States
ID NLM: 7502021
Informations de publication
Date de publication:
09 2021
09 2021
Historique:
revised:
31
12
2020
received:
18
10
2020
accepted:
12
01
2021
pubmed:
2
2
2021
medline:
3
3
2022
entrez:
1
2
2021
Statut:
ppublish
Résumé
An 8 ton per year manufacturing facility is described based on the framework for integrated and continuous bioprocessing (ICB) common to all known biopharmaceutical implementations. While the output of this plant rivals some of the largest fed-batch plants in the world, the equipment inside the plant is relatively small: the plant consists of four 2000 L single-use bioreactors and has a maximum flow rate of 13 L/min. The equipment and facility for the ICB framework is described in sufficient detail to allow biopharmaceutical companies, vendors, contract manufacturers to build or buy their own systems. The design will allow the creation of a global ICB ecosystem that will transform biopharmaceutical manufacturing. The design is fully backward compatible with legacy fed-batch processes. A clinical production scale is described that can produce smaller batch sizes with the same equipment as that used at the commercial scale. The design described allows the production of as little as 10 g to nearly 35 kg of drug substance per day.
Identifiants
pubmed: 33522595
doi: 10.1002/bit.27697
pmc: PMC8453788
doi:
Substances chimiques
Antibodies, Monoclonal
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3323-3333Informations de copyright
© 2021 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals LLC.
Références
J Chromatogr A. 2015 Apr 10;1389:85-95
pubmed: 25748537
Biotechnol Prog. 2006 Jul-Aug;22(4):1163-9
pubmed: 16889394
J Biotechnol. 2017 Mar 20;246:52-60
pubmed: 28159614
Biotechnol Prog. 2017 Sep;33(5):1323-1333
pubmed: 28649713
J Chromatogr A. 2016 Mar 11;1437:158-167
pubmed: 26879457
Biotechnol Appl Biochem. 2005 Oct;42(Pt 2):133-42
pubmed: 15901236
Biotechnol Bioeng. 2021 Sep;118(9):3323-3333
pubmed: 33522595
Biotechnol Bioeng. 2015 Jul;112(7):1406-16
pubmed: 25683378
MAbs. 2009 Sep-Oct;1(5):443-52
pubmed: 20065641
Adv Colloid Interface Sci. 2012 Aug-Sep;176-177:1-17
pubmed: 22560722
Cytotechnology. 1996 Jan;22(1-3):3-16
pubmed: 22358910
Biotechnol Bioeng. 2018 Nov;115(11):2751-2759
pubmed: 30080936
Biotechnol Bioeng. 2014 Jul;111(7):1365-73
pubmed: 24522836
Prep Biochem Biotechnol. 2018 May 28;48(5):383-390
pubmed: 29509101
BMC Proc. 2011 Nov 22;5 Suppl 8:P103
pubmed: 22373057
Biotechnol J. 2018 Oct;13(10):e1800036
pubmed: 29957873
Biotechnol Prog. 2013 May-Jun;29(3):754-67
pubmed: 23436789
Biotechnol Prog. 2013 May-Jun;29(3):768-77
pubmed: 23436783
Biotechnol Bioeng. 2021 Apr;118(4):1721-1735
pubmed: 33491769
Biotechnol Prog. 2019 Mar;35(2):e2763
pubmed: 30520568
Biotechnol Prog. 2017 Sep;33(5):1294-1302
pubmed: 28556575
Biotechnol Bioeng. 1999 Aug 5;64(3):349-56
pubmed: 10397872