Authors: Dr. Priya Kapoor, Mr. Sameer R. Joshi
Abstract: Biosimilars and biopharmaceuticals have emerged as key therapeutics due to their efficacy and targeted action. Analytical characterization of these complex molecules poses unique challenges owing to their large molecular size, heterogeneity, and sensitivity to environmental conditions. Critical analytical challenges include structural characterization, post-translational modifications analysis, impurity profiling, stability studies, and bioassay validation. Advanced techniques such as high-resolution mass spectrometry, capillary electrophoresis, chromatography, and spectroscopy, coupled with multivariate data analysis, play a vital role in addressing these challenges. This paper reviews current analytical strategies, highlights major hurdles, and presents tables summarizing analytical techniques, their applications, and limitations. The integration of advanced analytical tools ensures robust quality control, regulatory compliance, and reliable clinical outcomes in biosimilar and biopharmaceutical research.
Keywords: Biosimilars, Biopharmaceuticals, Analytical Challenges, Mass Spectrometry, Chromatography, Stability Studies, Quality Control
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