Comparability studies are structured scientific assessments conducted to demonstrate that a change in the manufacturing process, facility, scale, or equipment does not adversely affect the quality, safety, or efficacy of a biological product. They involve a side-by-side evaluation of physicochemical, biological, and functional attributes of pre- and post-change material, and are required by regulatory agencies such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA) in accordance with ICH Q5E guidelines.
