Subunits difficulties associated with

As a result of the complex structure of the proteins, formulation of protein therapeutics pose unique difficulties as it is susceptible to physical and chemical instabilities. The complexity develops from the hierarchical nature of its structure primary, secondary, tertiary, and quaternary structures. Primary structure is the amino acid sequence of the polypeptide chains secondary structure refers to local-ordered conformation tertiary structure deals with the spatial arrangement of secondary structural elements (often referred as global fold) and the quaternary structure is the spatial arrangement of subunits. In general, chemical instability is related to primary structure of the protein, whereas physical instability is associated with the global fold or 3D structure of the molecule. The common problems encountered for protein products are listed in Table 6.2-1. 

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