Characterization Of Biotechnological Pharmaceuticals

From the formulation point of view, the determination of, for instance, purity and structural changes of proteins when they are exposed to denaturing conditions, effects from addition of the excipients, effects from preparation of the drug delivery system, and stability are some of the main concerns. Major considerations, when choosing the methods for studying the stability of proteins, are the complexity of the formulation and the excipients used. In Table 7, a list of methods is given as well as a brief overview of the advantages and disadvantages of the method in a formulations study. For further insight into methods to examine protein formulations and structural stability, the reader is suggested to consult the following (124,147-149).

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