(585f) PAT Data Management As a Tool to Support Continuous Production in Secondary Manufacturing

Pamela Docherty, Siemens, Vertical Pharma

Kjell Francois, Siemens NV, Vertical Pharma

Pharmaceutical secondary manufacturing has long stood in vast contrast to the drug discovery end of the business, as well as to other sectors, when it comes to innovation such as continuous manufacturing. Is that about to change? We argue that the coming decade could see secondary manufacturing not just catch up but leapfrog other sectors but that mindset will be a crucial factor.

Secondary manufacturing has been for a long time an inefficient and time consuming part of the production cycle. Now, however, the traditional business model is breaking down with consequent pressures on all parts of the pharma value chain. Manufacturing’s contribution to improving yield, reducing time, cost and waste is increasingly critical. Regulation which previously had insisted on batch testing is now moving to be much more supportive of real time product release and process analysis, heralding a future where the validation and establishment of continuous manufacturing will be easier.

Currently, more and more companies are making the move towards Continuous manufacturing. Smart data solutions must be provided on order to streamline the dataflow and get the essential information out of the big data stream. In this presentation we are diving in the mechanism of continuous manufacturing, leaving the isolated ‘islands of automation’ and working towards a fully integrated approach. Based on a couple of real established use cases we will explain how a PAT approach can be established in a continuous manufacturing area.