Monoclonal antibody purification and its progression to commercial scale.
Biologics
Chromatography
Monoclonal antibody
Purification
Therapeutic molecule
Journal
Biologicals : journal of the International Association of Biological Standardization
ISSN: 1095-8320
Titre abrégé: Biologicals
Pays: England
ID NLM: 9004494
Informations de publication
Date de publication:
Jan 2020
Jan 2020
Historique:
received:
16
04
2019
revised:
24
08
2019
accepted:
17
09
2019
pubmed:
29
9
2019
medline:
22
10
2020
entrez:
28
9
2019
Statut:
ppublish
Résumé
With the advancements in upstream technologies, the capacity for monoclonal antibody (mAb) production has transformed from a few milligrams to grams per liter. These titers lead to enormous pressure on downstream processes (DSPs), which need to be reworked to achieve higher efficiency and better utilization of available resources. Various parameters, such as column sizing, aggregate removal, filtration and volume handling, must be considered while designing a facility for commercial scale. If any of these critical parameters are not defined during the facility design stage, collapse of the process can result, further resulting in commercial loss and delaying entry of the product into the market. Therefore, during the facility design stage, the process requirements, space utilization, process efficiency and advanced manufacturing systems must be evaluated appropriately before implementation on a commercial scale.
Identifiants
pubmed: 31558429
pii: S1045-1056(19)30105-8
doi: 10.1016/j.biologicals.2019.09.007
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-13Informations de copyright
Copyright © 2019 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.