“The Right Tools for the Job”: Case study in Fill Process Scale-up of a Viscous, High Concentration Protein Product

PROBLEM STATEMENT: The choice of filling technology for liquid protein products involves special considerations in the case of molecules exhibiting high viscosity and protein concentration. This case study reviews the special challenges associated with choosing a robust pump technology for filling of a biologic exhibiting high viscosity and protein concentration. Clear up-front definition of selection criteria is a key consideration in navigating the benefits and risks of currently available filling equipment. Process design and procedural controls also play a factor in ensuring an aseptic filling process that is robust to the effects of protein solution flow and evaporation. Appropriately designed fill development studies can provide value in optimizing the process and characterizing scale effects prior to moving to commercial production. DESIRED LEARNING OUTCOMES FROM THIS PRESENTATION: - Understand unique design criteria required for filling proteins of high viscosity and protein concentration - Raise awareness of the potential pitfalls associated with pump characterization scale-up