A systematic model development framework for pharmaceutical batch crystallization processes using an iterative model-based experimental design approach

K. Hemalatha

doi:10.1016/j.ces.2026.123886

A systematic model development framework for pharmaceutical batch crystallization processes using an iterative model-based experimental design approach

2026-03-29

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Charles D. Papageorgiou

Z

Zoltan K. Nagy *

DOI：10.1016/j.ces.2026.123886

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Abstract

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• Iterative MBDoE framework presented for systematic crystallization model development. • IMED integrates model discrimination and precise parameter estimation steps. • Model discrimination employs statistical tests with optimal experimental design. • Framework validated in in-silico case studies and pharmaceutical API crystallization. • Enables rapid process understanding and predictive digital twin applications.

Keywords:

Iterative Model-Based Experimental Design

Crystallization Model Development

Statistical Model Discrimination

Parameter Estimation

Digital Twin

A systematic model development framework for pharmaceutical batch crystallization processes using an iterative model-based experimental design approach

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