Functional design of experiment for potency assay optimization and in-silico simulation.
Bioassay
Functional design of experiment
In-silico optimization
Parameter criticality assessment
Potency assay
Robustness analysis
Journal
Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Titre abrégé: J Pharm Biomed Anal
Pays: England
ID NLM: 8309336
Informations de publication
Date de publication:
20 Sep 2023
20 Sep 2023
Historique:
received:
11
04
2023
revised:
20
06
2023
accepted:
14
07
2023
medline:
24
7
2023
pubmed:
24
7
2023
entrez:
23
7
2023
Statut:
ppublish
Résumé
For biotherapeutic analytics, robust and reliable potency assays are required. Design of experiment (DoE) approaches are used to investigate the impact of multiple assay parameters. Currently, specific assay features (e.g., half effective concentration) are modelled independently from each other. A joint interpretation of several assay features is thus difficult. In our functional DoE approach, we use the functional relationship of the assay features to describe the sigmoidal dose-response curve. With the composed functional form, the direct impact of assay parameters on the dose-response curve shape was modelled. Moreover, a multivariate desirability was defined and used for assay optimization. We believe that functional modelling contributes to understanding the joint influence of assay parameters and helps to design robust biotherapeutic analytics.
Identifiants
pubmed: 37481901
pii: S0731-7085(23)00353-9
doi: 10.1016/j.jpba.2023.115584
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115584Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.
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.