Kelly A. Swinney, Ph.D
This presentation will begin with an overview of the business drivers that led to commercial drug product continuous manufacturing at Vertex. Process development, filing, inspection and CGMP manufacturing experiences will be shared. Included will be a review of anticipated hurdles, surmountable challenges, and the unforeseen organizational benefits of implementing continuous manufacturing. Control strategy development considerations, such as equipment capability, process complexity, segregation, in-process controls, and the need for real time decision making will be discussed. A fully automated, commercial control strategy based on process analytical technology will be presented. Process control examples, sampling plans, the associated statistical sampling plan justifications and the business rationale for the implementation of redundant in-process control methods will be shared. The tangible benefit of real time release testing will be discussed and commercial manufacturing approved real time release testing approaches for the evaluation of a continuously manufactured batch will be described. Finally general considerations for maximizing the operational efficiency of continuous manufacturing will be discussed.