Process development for Fill & Finish activities of large molecule parenterals requires an orchestrated effort of multiple functions to deal with product specific critical quality attributes (CQAs) and critical process parameters (CPPs). Analytical development, drug product development, and manufacturing sciences are responsible for the development and implementation of robust processes and analytical methods that allow for enhanced execution of mixing, filtration, and filling of the drug product at the respective site and filling line.
In this webinar, we will learn from Dr. Marcel Tigges about some of the production challenges faced by researchers working on large molecule process development. At Janssen, Dr. Tigges and his team are developing innovative solutions to the processes by implementing new technologies for monitoring protein conformational stability (nanoDSF), protein concentration (PAT-FlowVPE) and computational modeling (CFD) to further optimize monitoring of CQAs and CPPs and prepare for Pharma 4.0. Additionally, we will hear from Dr. Silvia Würtenberger, on how Prometheus is the new gold standard that precisely characterizes protein stability by looking at thermal and chemical unfolding of proteins in a label-free way, using a tiny amount of sample.