(284b) The Development of Integrated Continuous Drug Substance Processes

Authors: 
Whelan, J., University College Dublin
Barrett, M., APC Ltd
Glennon, B., APC Ltd.
As pressure grows on pharmaceutical companies to deliver increasing levels of process performance, reduced capital and manufacturing costs the industry is looking more and more to continuous processing to help tackle some or all of these challenges.

Within this presentation case studies will be presented where unique continuous processing hybrid platforms have been utilised for the development and operation of continuous processes. These processes included heterogeneous and homogenous chemistries, work-up/distillations, crystallization and isolation. Specifically within the case studies presented details will be outlined, via PAT integration, engineering kinetic and statistical models, experimental and lab rig design, required to enable the design, optimisation and operation of these platforms over multiple week long periods. During the presentation the design considerations over CSTRs, PFRs, hybrid or novel reactor design configurations will be presented and how such design selections can impact or tailor the design properties of the intermediates and importantly the final API solid state characteristics.