Abstract
The need to carry out extensive physicochemical characterization of protein and monoclonal antibody molecular structure, employing multiple, complementary, as well as orthogonal, state-of-the-art analytical methods, is stressed. The three major pathways for molecular structural changes that can occur will be examined: primary amino acid sequence changes (e.g., truncation, deamidation, oxidation), posttranslational modifications (e.g., glycosylation), and higher-order structural changes (e.g., secondary folding, aggregation). In addition, in this chapter, it will be shown that a clinical phase-appropriate approach can be applied to this physicochemical structural characterization. Finally, the challenge of molecular structure characterization of gene therapy vectors and whole-cell nonprotein biologics will also be discussed.
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Albert Einstein, Nobel laureate in physics, 1879–1955
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Geigert, J. (2013). Molecular Structural Analysis. In: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6916-2_9
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DOI: https://doi.org/10.1007/978-1-4614-6916-2_9
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