Robust mechanistic modeling of protein ion-exchange chromatography.
Breakthrough curve
Colloidal isotherm
Mechanistic modeling
Monoclonal antibody
Parameter estimation
Protein ion-exchange chromatography
Journal
Journal of chromatography. A
ISSN: 1873-3778
Titre abrégé: J Chromatogr A
Pays: Netherlands
ID NLM: 9318488
Informations de publication
Date de publication:
20 Dec 2021
20 Dec 2021
Historique:
received:
27
08
2021
revised:
20
10
2021
accepted:
31
10
2021
pubmed:
21
11
2021
medline:
15
12
2021
entrez:
20
11
2021
Statut:
ppublish
Résumé
Mechanistic models for ion-exchange chromatography of proteins are well-established and a broad consensus exists on most aspects of the detailed mathematical and physical description. A variety of specializations of these models can typically capture the general locations of elution peaks, but discrepancies are often observed in peak position and shape, especially if the column load level is in the non-linear range. These discrepancies may prevent the use of models for high-fidelity predictive applications such as process characterization and development of high-purity and -productivity process steps. Our objective is to develop a sufficiently robust mechanistic framework to make both conventional and anomalous phenomena more readily predictable using model parameters that can be evaluated based on independent measurements or well-accepted correlations. This work demonstrates the implementation of this approach for industry-relevant case studies using both a model protein, lysozyme, and biopharmaceutical product monoclonal antibodies, using cation-exchange resins with a variety of architectures (SP Sepharose FF, Fractogel EMD SO
Identifiants
pubmed: 34800897
pii: S0021-9673(21)00791-3
doi: 10.1016/j.chroma.2021.462669
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Cation Exchange Resins
0
Sepharose
9012-36-6
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
462669Informations de copyright
Copyright © 2021. Published by Elsevier B.V.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors have no interests to declare.