Improve Product Quality

Protein aggregates in final drug product formulations may reduce the activity of the protein and increase its immunogenicity. While activity losses may be addressed by increasing the dose administered to the patient, the increased immunogenicity is a major concern for chronic administration of protein therapeutics. Immune reactions from therapeutic protein aggregates have often resulted in the formation of neutralizing antibodies that inhibit the function of endogenous protein. In some cases, the generation of neutralizing antibodies to the endogenous protein can be life threatening to the patient. Regulatory authorities have recently proposed reducing levels of protein aggregates in therapeutic products to minimize immunogenicity concerns.

In the manufacture of proteins, aggregation may occur at several points in the process from the initial cell harvest through the final formulation. BaroFold’s PreEMT technology is able to dissociate aggregates and recover native protein from any step in the process, thus ensuring an essentially ‘aggregate-free’ final drug product. PreEMT treated protein products are generally more homogeneous compared to products produced with conventional methods. BaroFold has demonstrated that generating an ‘aggregate-free’ final drug product also leads to significant improvements in stability possibly enabling room temperature stable liquid products. In addition, BaroFold has shown that the immunogenicity of PreEMT treated protein preparations is significantly reduced compared to the initial protein preparations in animal models.

Overall, by utilizing PreEMT technology in protein manufacturing, the product quality may be significantly increased, reducing immunogenicity concerns and setting a higher quality standard for potential competitors.