Comprehensive Characterization Of Biologics

Biophysical characterization plays a crucial role in the development of biopharmaceuticals, including both innovator biologics and biosimilars. The physical and biological behavior of proteins significantly impacts various aspects of a biologic drug, such as its function, activity, and stability.

Biophysical analytical techniques are essential for assessing key properties, such as conformational integrity, the protein's folded state, and the interactions between peptides that form complex physical structures. It is also vital to consider how drug substances interact with excipients during formulation development, stability studies, and comparability assessments, as these interactions can influence protein structure and product stability. Additionally, biophysical methods are invaluable in studying protein degradation and aggregation, both of which are critical factors in maintaining the integrity and efficacy of biologic drugs.