[4S06e] 17. Downstream processing - Part 3

5:15 PM - 5:35 PM JST(8:15 AM - 8:35 AM UTC)

[4DSP-11] Chromatographic Simulation as a Practical Tool to Enhance Antibody Process Development and Decision Quality

○Hiroya Okura¹, Yohei Nomura¹, Kei Sato¹, Hidenori Inaba¹, Mitsutaka Matsuura¹ (1. Astellas Pharma Inc. (Japan))

Keywords:

Mechanistic model,chromatography,simulation

The manufacturing process of antibody therapeutics consists of an upstream cell culture step, in which antibodies are produced using cells, and a downstream purification step to obtain highly pure drug substances. In general, multiple chromatography steps are required in the purification process to remove numerous impurities, and the process development faces different constraints and bottlenecks in the early and late stages of drug development. In this presentation, we introduce case studies in which chromatographic simulation was applied as an efficient process development approach to address these issues. In early development, where sample availability for experiments is limited, chromatographic simulation enabled rapid process screening and platform applicability assessment, thereby improving the accuracy of risk evaluation. In late development, where numerous experiments are required to finalize commercial processes under the Quality by Design concept, chromatographic simulation made it possible to identify unexpected non-viable conditions and behaviors near the Edge of Failure in Design of Experiment studies in advance, contributing to higher-quality experimental planning. Thus, chromatographic simulation functions as a practical tool that complements experiments, streamlining process screening in early development and process understanding and DoE design in late development, ultimately contributing to shorter development timelines and reduced costs. Furthermore, when combined with automation driven by digital transformation (Dx), it is expected to become a tool that enables a dramatic increase in experimental efficiency in the future.