The present project aims to deliver a unique platform for monoclonal antibodies (mAb) crystallisation based on a modular oscillatory flow plate reactor (MOFPR), with enhanced hydrodynamic and transport properties. Specific objectives:
1-Phase behaviour and solubility curve are assessed for the selected mAbs.
2-Implement design of experiments (DOE) and Response Surface Methodology to identify the process variables (i.e., oscillation conditions, supersaturation degree…) that affect most the performance of the system and system’s outcomes (i.e., induction time, crystal size and shape). The study is completed by the assessment of the stability of the produced crystalline suspensions.
3-Implement optical microscopy and spectroscopy tools for in-line monitoring of solution and crystals’ properties (CSD, shape). 4-A population balance (PB) model to describe CSD evolution and ML algorithms to develop models able to estimate values of unknown parameters or difficult to measure are developed.
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