Model Aided Development of HPLC Purifications

• Research unit: INNOSUISSE
• Project number: 16182.1 PFIW-IW

Short description (German)

Model Aided Development of HPLC Purifications

Short description (English)

Model Aided Development of HPLC Purifications

Abstract (German)

Reverse phase chromatography is a critical step for the synthesis of many APIs. Aim of this project is to provide advanced and QbD complaint numerical approaches for the selection, development and qualification of such purification processes. The novelty lies in the use of hybrid statistical and deterministic models, which allow a much deeper process understanding and, in turn, favors process quality work planning. Accordingly, it is possible to sensibly reduce development time and costs, production costs and increase process robustness.

Abstract (English)

Reverse phase chromatography is a critical step for the synthesis of many APIs. Aim of this project is to provide advanced and QbD complaint numerical approaches for the selection, development and qualification of such purification processes. The novelty lies in the use of hybrid statistical and deterministic models, which allow a much deeper process understanding and, in turn, favors process quality work planning. Accordingly, it is possible to sensibly reduce development time and costs, production costs and increase process robustness.