Team Leader, GSK Fellow GlaxoSmithKline Collegeville, Pennsylvania
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.
Learning Objectives:
to understand and acknowledge complexities involved while selecting and/or evaluating commercial scale mixing systems for Steriles product development.
to apprehend the importance of drug substance sparing surrogates’ evaluation, scaled-down experimentation, “predict first” mechanistic modelling and engineering calculations in compressed timelines of drug product development.
to differentiate the need of different mixing systems based on the properties of drug substance and drug product.