Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals

Category: Commentary
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Keywords: analysis, biosimilar, protein, spectroscopy, structure

Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher order structures. It finds that, although other methods exist, spectroscopic methods remain most commonly used.

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