The PAT Monitoring and Control Workstream mobilized in May 2018 and has representation from 23 member companies. Their mission is to address how best to get from concept to regulatory approval using new Process Analytical Techniques (PAT) and to develop a collaboration view that can be shared with the industry.
During 2020, the team aims to summarize the results of their baseline survey and the resulting data collection and assessment of PAT technologies against business drivers in a white paper titled Systematic Assessment of PAT Applications for Biologics which will help companies understand which technologies are used during each phase and individual unit operations in the development lifecycle and manufacturing of a therapy, all according to a number of business drivers and attributes.
A number of new topics have been identified for further discussion; in 2020 covering the Implementation of PAT which aims to develop a roadmap for adoption of specific technologies from development into manufacturing and work on Value Propositions which will address how to deliver value in support of acceleration and process modelling.
The team maintains close links to the Inline Monitoring and Real Time Release and Rapid Methods teams within the Technology Roadmap Phorum to ensure alignment.