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
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

462669

Informations 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.

Auteurs

Vijesh Kumar (V)

Department of Chemical and Biomolecular Engineering, University of Delaware, Newark, DE 19716, United States.

Samuel Leweke (S)

IBG-1: Biotechnology Forschungszentrum Jülich GmbH, 52425 Jülich, Germany.

William Heymann (W)

IBG-1: Biotechnology Forschungszentrum Jülich GmbH, 52425 Jülich, Germany; Amgen Process Development, One Kendall Square, 360 Binney St., Cambridge, MA 02141, United States.

Eric von Lieres (E)

IBG-1: Biotechnology Forschungszentrum Jülich GmbH, 52425 Jülich, Germany.

Fabrice Schlegel (F)

Amgen Process Development, One Kendall Square, 360 Binney St., Cambridge, MA 02141, United States.

Karin Westerberg (K)

Amgen Process Development, One Amgen Center Drive, Thousand Oaks, CA 91360, United States.

Abraham M Lenhoff (AM)

Department of Chemical and Biomolecular Engineering, University of Delaware, Newark, DE 19716, United States. Electronic address: lenhoff@udel.edu.

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Classifications MeSH