Changes in Manufacturing Processes of Biologic Therapies Can Alter the Immunogenicity Profile of the Product
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DOI: 10.1002/cpt.1694
Abstract: Manufacturing process changes may alter the characteristics of a protein therapeutic. In 2009, somatropin (version 1.0), a recombinant human growth hormone therapeutic, underwent a manufacturing update (version 1.1). The immunogenicity of somatropin version 1.1 as… read more here.
Keywords: changes manufacturing; version; immunogenicity; somatropin version ... See more keywords