Formulation and Quality – Biomolecular
2019 PharmSci 360
Accelerated stability is a widely used and valuable tool in formulation/analytical/process development of protein-based drug candidates. Due to time pressure, quite often researchers attempt to super-accelerate the procedure by employing exaggerated stress on protein formulations. Such approaches tend to result in denatured/degraded states of protein that are seldom relevant to predicting pharmaceutical stability and degradation routes. This session will discuss best practices of accelerated stability approaches in various modules of biologics development (analytical method development/validation, formulation development, process development/characterization, long-term stability and trending) and science-based selection approaches for accelerated conditions. Case studies will be included in discussions.