Continuous Manufacturing – Accomplishments, Opportunities, and Challenges
*Paul Collins, Eli Lilly and Company 


Continuous manufacturing (CM) of pharmaceuticals offers many attractive benefits to both industry and regulatory authorities. From an innovation perspective, the technologies allow for greater flexibility to design molecules. From a cost perspective, CM promises lower capital footprints, flexibility in equipment deployment, and a faster drug development timeline. Opportunities for advancement in quality control approaches exist as well, due to the greater ability to control outputs in real time. The presentation will discuss some of these opportunities and demonstrate with implemented examples from relevant manufacturing scales. The presentation will then move to discuss the new capability sets needed to fully harness and implement CM, with a special emphasis on how the fields of statistics and advanced mathematics might optimally be utilized.