Technical / White Paper
CONFIDENCE IN BIOLOGICS FORMULATION DESIGN
To ensure a long product shelf-life for biopharmaceutical drug products, a stable storage environment is critical. Determination of the optimal environment is initiated early in the development process through preformulation screening. In order to maintain potency and activity of protein active pharmaceutical ingredients (APIs), preservation of structural conformation—a characteristic highly influenced by formulation environment—is essential. In this article we describe the use of various biophysical techniques as formulation screening tools, aiding elucidation of protein conformation and protein dynamics.