Scale-up of Pharmaceutical Manufacturing Processes: A QbD Approach

Scale-up of a pharmaceutical manufacturing process can present many exciting engineering challenges. As the industry moves from more historical approaches of process scale-up that may have involved re-development of a process on larger scales to an approach where process understanding is the basis for the development, the tools needed to address these challenges have changed. Multivariate data analyses, process monitoring tools, mathematical modeling techniques, statistical process control, and other powerful process interrogation tools have become more prevalent in the industry under the umbrella of QbD and provide insight for engineers to scale processes more logically and efficiently. This session is meant to capture best practices for the use of these tools, identify where the industry is driving in terms of extension of these tools to more complex systems, and how scale-up has been enhanced by the use of advanced QbD based techniques such as those listed above. Papers concerning all areas of pharmaceutical scale-up, from small molecules to biologics, from drug substances to drug products, will be considered.