Course of growth for Fill & End actions of enormous molecule parenterals requires an orchestrated effort of a number of capabilities to cope with product particular crucial high quality attributes (CQAs) and demanding course of parameters (CPPs). Analytical growth, drug product growth, and manufacturing sciences are accountable for the event and implementation of sturdy processes and analytical strategies that permit for enhanced execution of blending, filtration, and filling of the drug product on the respective web site and filling line.
On this webinar, we are going to study from Dr. Marcel Tigges about a few of the manufacturing challenges confronted by researchers engaged on giant molecule course of growth. At Janssen, Dr. Tigges and his crew are growing revolutionary options to the processes by implementing new applied sciences for monitoring protein conformational stability (nanoDSF), protein focus (PAT-FlowVPE) and computational modeling (CFD) to additional optimize monitoring of CQAs and CPPs and put together for Pharma 4.0. Moreover, we are going to hear from Dr. Silvia Würtenberger, on how Prometheus is the brand new gold customary that exactly characterizes protein stability by thermal and chemical unfolding of proteins in a label-free approach, utilizing a tiny quantity of pattern.