(213g) Evaluation and selection of mixing systems for sterile drug products with “predict first” smart process engineering, modeling and PAT approaches

Mixing operation could be challenging to scale-up for floating and settling particles for sterile drug products. This presentation will cover holistic smart process engineering approaches researchers can adopt while selecting and/or evaluating mixing systems. These approaches are underpinned by API sparing surrogates’ evaluation, “predict first” mechanistic modelling, engineering calculations and scaled-down experimentation. In this presentation, we will a) understand and acknowledge complexities involved while selecting and/or evaluating commercial scale mixing systems for Steriles product development, b) apprehend the importance of drug substance sparing surrogates’ evaluation, scaled-down experimentation, “predict first” CFD - mechanistic modelling and engineering calculations in compressed timelines of drug product development, c) learn the need of different mixing systems based on the properties of drug substance and drug product.