Chemical and Analytical Strategies for Biosimilars

Chemical and analytical strategies play a vital role in the development and characterization of biosimilars. These strategies aim to establish comparability between the biosimilar and the reference biologic by assessing their physicochemical properties, purity, and potency. Various analytical techniques, such as mass spectrometry, chromatography, and spectroscopy, are employed to evaluate critical quality attributes (CQAs) of the biosimilar. Additionally, advanced structural analysis techniques, including X-ray crystallography and nuclear magnetic resonance (NMR) spectroscopy, are used to examine the higher-order structure of the biosimilar. These strategies enable a comprehensive understanding of the biosimilar's molecular characteristics, facilitating the identification of potential differences and ensuring the safety and efficacy of the product.

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