4196985

Integration of mechanistic modelling and high-throughput chromatography for enhanced study design for biologics process characterization

Date
March 27, 2025

The increasing demand for new biologics necessitates the acceleration of process characterization (PC) studies. We have previously demonstrated that high-throughput (HTP) small-scale chromatography, performed by a multi-channel liquid handling robot is a suitable alternative to traditional bench-scale scale down models (SDM) for PC studies. Incorporation of a mechanistic modeling workflow prior to PC allows for an in silico, predictive approach to experimental design, thereby reducing overall resource burden while simultaneously enhancing the final design space during PC studies. These improvements can expedite data generation and result in more representative proven acceptable ranges.

We demonstrate a validated and platformed workflow for in silico process characterization of chromatography unit operations. This workflow leverages the mechanistic model developed using bench-scale model. PC design of experiments (DOE) studies will be performed on a qualified HTP SDM to verify the mechanistic model across a wider process design space to enhance process understanding. This approach to process characterization reduces cost and material requirements compared to traditional screening and PC studies without compromising quality nor safety of future commercial batches and reduces the time to bring new products to market (and thereby the patient).

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