Stability Services

A significant hurdle in developing biopharmaceuticals, including recombinant proteins and microbial products, is demonstrating stability. Regulatory agencies expect a thorough experimental evaluation of degradation pathways and a defined shelf life due to the inherent complexity of these molecules, which renders their degradation unpredictable (i.e., not following Arrhenius kinetics) because of multiple interacting pathways. Consequently, proving the stability of clinical trial material is a prerequisite before human clinical studies can commence.