(758b) Chemical Engineering Strategies to Directly Deliver Process Properties Across Development and Manufacturing Scales

Glennon, B. - Presenter, University College Dublin
Carr, M., APC Ltd
Whelan, J., University College Dublin
Barrett, M., APC Ltd

In recent years there has been a growing necessity to reduce the time, cost and risk associated to the development and scale-up of pharmaceutical processes. The increasing pressures to direct deliver critical quality attributes (CQAs) and process performance criterion (cycle times, capacities etc) across manufacturing and supply scales compounding this challenge. As a result of this process engineering strategies, to enable streamlined, reliable and robust scale-up, has become increasing important.

Within this presentation novel process engineering strategies and technologies, underpinned by process modelling, will be presented that enable the delivery of process characteristics (i.e. particle size, shapes, PSDs, flowability, reaction purities, process kinetics etc). Applications of advanced process control, process simulation, kinetic assessments, particle engineering strategies, processing technologies (batch and continuous) will be discussed via numerous development and scale-up case studies.