Biotherapeutics are the fastest growing class of pharmaceutical with a rapidly evolving
market facing the rise of biosimilar and biobetter products. In contrast to a biosimilar, which
is derived from the same gene sequence as the innovator product, a biobetter has enhanced
properties, such as enhanced efficacy or reduced immunogenicity. Little work has been
carried out so far to increase the intrinsic stability of biotherapeutics via sequence changes,
even though, aggregation, the primary degradation pathway of proteins, leads to issues …

SAP results for the IgG1 fragment crystallizable (Fc) region are common to all IgG1 mAbs.
There are several high SAP residues found in the Fc region, however these residues are
either involved in Fc receptor binding, involved in Protein A/G binding (which is the most
common and desirable purification method), buried by glycosylation, or are located in the
interior region of the dimer structure (Fig. S1). 1 Hydrophilic mutations of high SAP region in
the Fc domain were shown to lead to more stable mAbs with reduced aggregation …