The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in pharmaceutical development and manufacturing. The active substances have become more structurally complex and R&D timelines continue to be compressed, the chemistry and technologies necessary to provide safe, robust and economical access to these molecules needs to keep pace.
Automation and information management technologies are increasingly being used in the development and manufacturing of therapeutics across the pharmaceutical industry to collect, analyze, and interpret an immense amount of advantageous process data that would otherwise be inaccessible. This combination provides many additional benefits, such as enabling processes, ability to safely handle highly reactive, unstable, and toxic reagents. All these aspects help to minimize the time and cost associated with development and manufacture of drugs and bring medicines to patients more effectively. The importance of such concepts has become even more evident in recent Covid-19 pandemic crisis, different organizations are actively thinking of implementing these paradigms to their benefit. In order to fully leverage and integrate the larger organization, end-to-end automation and information management strategy and vision is necessary where there is seamless workflow for automated route screening to optimization and scale-up of robust process is established. This presentation will share AbbVie’s strategy and experiences in integrating such end-to-end technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches.