Published Paper Details:

Background: Biologics, derived from living organisms, are pivotal in treating life-threatening conditions such as cancer and autoimmune diseases. This article aims to provide a comprehensive overview of biologics and biosimilars, emphasizing their types, molecular characterizations, and recent analytical advancements. Main Body of the Abstract: This review addresses: Introduction to Biologics: Covering their diverse nature and applications in treating various illnesses. Types of Biologics: Expanding on monoclonal antibodies, recombinant DNA technology products, biological response modifiers and their therapeutic significance Introduction to Biosimilars: Discussing the challenges in replicating these drugs due to inherent variability and complex manufacturing processes Molecular Characterization of Biosimilars: Exploring primary and higher-order structures, glycosylation, product-related variants, and process-related variants as key areas of analysis Recent Analytical Advances: Highlighting advancements in techniques such as liquid chromatography-mass spectrometry (LC-MS), two-dimensional polyacrylamide gel electrophoresis (2D-PAGE), and enzyme-linked immunosorbent assay (ELISA) for host cell protein (HCP) analysis. Short Conclusion: Recent analytical advancements address limitations in HCP detection and identification, contributing significantly to ensuring the quality, safety, and efficacy of biologics in the pharmaceutical industry.