Protein aggregates in final drug product formulations may reduce the activity of the protein and increase its immunogenicity, resulting in the formation of neutralizing antibodies that inhibit the endogenous protein and may even be life-threatening. Regulatory authorities have recently proposed reducing levels of protein aggregates in therapeutic products to minimize these immunogenicity concerns.
High pressure treatment through PreEMT is non-denaturing and effectively removes protein aggregates in all phases of protein manufacturing, including final bulk drug substance. BaroFold has demonstrated that aggregate-free compositions have unique composition of matter claims based on the reduced immunogenicity and increased bioavailability attributes of these new compositions, which facilitates life-cycle extension strategies. Preliminary studies have also shown that high pressure treatment can facilitate protein crystal formation, resulting in highly homogeneous crystals ideal for sustained delivery and other life-cycle management initiatives.