Pharmaceutical Biotechnology.pptVIP

Figure 4.5: Task tree for the structural characterization of a therapeutic protein. * The purification protocol is designed carefully, as it usually forms the basis of subsequent pilot- and process-scale purification systems. The purified product is then subjected to a battery of tests that aim to characterize it fully. In addition to the studies listed in Figure 4.5, stability characteristics of the protein with regard to e.g. temperature, pH and incubation with various potential excipients are studied. Such information is required in order to identify a suitable final product formulati