Quality by Design approaches to assessing the robustness of tangential flow filtration for MAb.
Multivariate analysis
Process characterization
Process robustness
Quality by design (QbD)
Tangential flow filtration (TFF)
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:
05
06
2019
revised:
06
12
2019
accepted:
07
12
2019
pubmed:
19
12
2019
medline:
22
10
2020
entrez:
19
12
2019
Statut:
ppublish
Résumé
Quality by Design (QbD) is a modern approach for quality assurance in pharmaceutical production. This article illustrates a case study of TFF robustness performed for a process characterization of a monoclonal antibody under QbD principles by exploring functional relationships that link the process parameters to quality/process attributes with prior process knowledge, risk assessment, and multivariate experiments. In every case of quality or process attributes, all measured values were in alignment with the allowable specification range, and the developed models were non-significant and had no lack of fit, thus confirming the robustness of the TFF process within the tested ranges of process parameters.
Identifiants
pubmed: 31848036
pii: S1045-1056(19)30132-0
doi: 10.1016/j.biologicals.2019.12.001
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
53-61Informations de copyright
Copyright © 2019 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest This work was funded and supported by Dong-A Socio Holdings and Merck Ltd. Korea. Hyun Wee, EunJeong Bae and Taekyeol Lee are employees of Dong-A Socio Holdings and KeunHoe Koo is an employee of Merck Ltd. Korea.