Roles of mechanistic, data-driven, and hybrid modeling approaches for pharmaceutical process design and operation

Author:

Gaddem Mohamed Rami,Kim Junu,Matsunami Kensaku,Hayashi Yusuke,Badr Sara,Sugiyama Hirokazu

Funder

Japan Society for the Promotion of Science

AMED

Publisher

Elsevier BV

Reference71 articles.

1. A review on the modernization of pharmaceutical development and manufacturing — trends, perspectives, and the role of mathematical modeling;Destro;Int J Pharm,2022

2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: ICH Quality Implementation Working Group — Points to Consider (R2) — ICH-Endorsed Guide for ICH Q8/Q9/Q10 Implementation (n.d.); 〈https://database.ich.org/sites/default/files/Q8_Q9_Q10_Q%26As_R4_Points_to_Consider_2.pdf〉 (accessed November 14, 2023).

3. Bioprocessing in the digital age: the role of process models;Narayanan;Biotechnol J,2020

4. A PSE perspective for the efficient production of monoclonal antibodies: integration of process, cell, and product design aspects;Badr;Curr Opin Chem Eng,2020

5. Hybrid models based on machine learning and an increasing degree of process knowledge: application to capture chromatographic step;Narayanan;Ind Eng Chem Res,2021

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1. Editorial overview: Model-based process design;Current Opinion in Chemical Engineering;2024-12

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