A novel framework of surrogate-based feasibility analysis for establishing design space of twin-column continuous chromatography.
Int J Pharm
; 609: 121161, 2021 Nov 20.
Article
en En
| MEDLINE
| ID: mdl-34624445
Multi-column periodic counter-current chromatography (PCC) has attracted wide attention for the primary capture for the purpose of achieving continuous biomanufacturing. Consequently, determining the design space of the continuous capture process is very important to facilitate process understanding and improving product quality. In this work, we proposed a novel approach to identify the design space of continuous chromatography to balance the computational complexity and model predictions. Specifically, surrogate-based feasibility analysis with adaptive sampling is applied to establish the design space of twin-column CaptureSMB process. The surrogate model is constructed based on the developed mechanistic model for the identification of the design space. The effects of process variables (including interconnected loading time, interconnected flowrate, and batch flowrate) on the design space are comprehensively examined based on an active set strategy. Besides, essential factors like recovery-regeneration time and constraints of column performance parameters (yield, productivity, and capacity utilization) are thoroughly investigated. The impact of design variables such as column length is also studied.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proteína Estafilocócica A
Tipo de estudio:
Prognostic_studies
Idioma:
En
Revista:
Int J Pharm
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Países Bajos