Biosimilarity and batch-to-batch comparability

DSC is an established analytical tool used for higher order structure (HOS) comparability studies of biopharmaceuticals, and for HOS analysis during development of biosimilars. Comparison of DSC thermograms from a reference protein with a new batch of the protein is used to assess the similarity of the conformational stability of the two proteins. Comparability studies are also performed if there is a process change, to ensure the change does not affect protein stability. DSC is also utilized as an analytical tool during the development of biosimilars, where DSC thermograms for the biosimilar are compared to the parent (innovator) drug product.

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