Authors: Dr. Meenakshi Sharma, Dr. Arvind Kumar
Abstract: Biologics, also known as large molecules, represent a rapidly growing sector of the pharmaceutical industry due to their therapeutic potential, specificity, and ability to target complex disease pathways. Unlike small molecules, biologics such as monoclonal antibodies, recombinant proteins, vaccines, and gene therapies are structurally complex, heterogeneous, and sensitive to production environments. Their analysis requires specialized methodologies that can ensure product quality, safety, and efficacy. The analytical evaluation of large molecules involves multiple stages, including structural characterization, purity assessment, functional testing, and stability studies. This paper provides a comprehensive discussion on the analytical strategies for biologics, highlighting advanced techniques such as mass spectrometry, chromatography, spectroscopy, and bioassays. It further reviews current literature, addresses major challenges in large molecule analysis, and identifies the scope for future advancements in biopharmaceutical development.
Keywords: Biologics, Large molecules, Analytical techniques, Monoclonal antibodies, Mass spectrometry, Chromatography, Biopharmaceutical analysis, Protein characterization, Therapeutic development
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