Statistical Analysis of HOS

Statistical analysis of the Higher Order Structure (HOS) of proteins plays a crucial role in establishing biosimilarity for new generic drugs. By understanding a protein’s higher-order structure, researchers can gain deeper insights into its function, which is essential for comprehending how living molecular machinery operates. Accurately determining protein structures is a significant advancement in scientific research, particularly in the development of drugs that mimic biological molecules.

While experimental methods like X-ray crystallography, NMR spectroscopy, and cryo-electron microscopy (cryo-EM) provide valuable structural information, these techniques are not always feasible or sufficient for every scenario. In such cases, computational statistical analysis of protein HOS becomes an essential tool. When combined with experimental data, statistical methods significantly enhance our understanding of HOS similarity, which is pivotal in evaluating the biosimilarity of drug candidates. This approach helps ensure that biosimilars perform similarly to their reference biologics in terms of efficacy, safety, and function.