Characterization

Scale-down process characterization studies performed using a qualified scale-down model are a critical part of licensure applications for biologics. KBI has significant expertise in the design and execution of these studies to enable customers to define their process control strategy to take forward manufacturing conformance/validation lots. The scale-down studies also create data that can justify process ranges and their classification through the creation of a design space for the process. This is in-line with current regulatory expectations in a post QbD guidance environment. Scale-down validation studies are also employed to supplement data that will be generated from the manufacturing scale conformance lots. These studies can serve to explore regions in the process operating space that would not ordinarily be explored at large-scale.