A model-based approach towards accelerated process development: A case study on chromatography
Abstrak
Process development is typically associated with lengthy wet-lab experiments for the identification of good candidate setups and operating conditions. In this paper, we present the key features of a model-based approach for the identification and assessment of process design space (DSp), integrating the analysis of process performance and flexibility. The presented approach comprises three main steps: (1) model development & problem formulation, (2) DSp identification, and (3) DSp analysis. We demonstrate how such an approach can be used for the identification of acceptable operating spaces that enable the assessment of different operating points and quantification of process flexibility. The above steps are demonstrated on Protein A chromatographic purification of antibody-based therapeutics used in biopharmaceutical manufacturing.
Topik & Kata Kunci
Penulis (3)
Steven Sachio
Cleo Kontoravdi
Maria M. Papathanasiou
Akses Cepat
- Tahun Terbit
- 2022
- Bahasa
- en
- Sumber Database
- arXiv
- Akses
- Open Access ✓