Design of an integrated continuous downstream process for acid-sensitive monoclonal antibodies based on a calcium-dependent Protein A ligand.
Integrated continuous downstream process
Mild purification
Monoclonal antibody
Process design
Z(Ca)
pH-sensitive antibodies
Journal
Journal of chromatography. A
ISSN: 1873-3778
Titre abrégé: J Chromatogr A
Pays: Netherlands
ID NLM: 9318488
Informations de publication
Date de publication:
08 Feb 2022
08 Feb 2022
Historique:
received:
15
11
2021
revised:
02
01
2022
accepted:
04
01
2022
pubmed:
17
1
2022
medline:
2
2
2022
entrez:
16
1
2022
Statut:
ppublish
Résumé
Monoclonal antibodies (mAb) are used as therapeutics and for diagnostics of a variety of diseases, and novel antibodies are continuously being developed to find treatments for new diseases. Therefore, the manufacturing process must accommodate a range of mAb characteristics. Acid-sensitive mAbs can severely compromise product purity and yield in the purification process due to the potential formation of aggregates. To address this problem, we have developed an integrated downstream process for the purification of pH-sensitive mAbs at mild conditions. A calcium-dependent Protein A-based ligand, called Z
Identifiants
pubmed: 35033788
pii: S0021-9673(22)00004-8
doi: 10.1016/j.chroma.2022.462806
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Ligands
0
Staphylococcal Protein A
0
Calcium
SY7Q814VUP
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
462806Informations de copyright
Copyright © 2022. Published by Elsevier B.V.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: SH has filed a patent application regarding the novel Z(Ca) domain.