Authors : Dr. Ramesh Kumar, Ananya Sharma
Abstract: Biosimilars and biopharmaceuticals represent a rapidly growing segment of the pharmaceutical industry due to their therapeutic potential in treating chronic and life-threatening diseases. The complex nature of biologics, including proteins, peptides, and monoclonal antibodies, poses significant analytical challenges during development. These challenges include structural characterization, post translational modifications, aggregation, immunogenicity, and batch-to-batch consistency. Advanced analytical techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), capillary electrophoresis (CE), nuclear magnetic resonance (NMR), and bioassays are essential for comprehensive evaluation. This paper reviews the analytical hurdles in biosimilar development, methods employed for quality control, and regulatory considerations. Tables summarize key analytical techniques, parameters assessed, and their applications. The discussion emphasizes the integration of orthogonal approaches to ensure safety, efficacy, and regulatory compliance of biosimilars and biopharmaceutical products.
Keywords: Biosimilars, biopharmaceuticals, analytical challenges, HPLC, mass spectrometry, capillary electrophoresis, protein characterization.
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