ReForm Biologics has expanded its patent portfolio with the issuance of U.S. Patent No. 10,279,048 (the ‘048 patent). The patent, entitled “Stabilizing Excipients for Therapeutic Protein Formulations,” provides ReForm exclusive rights to certain formulations and methods comprising an innovative new class of stabilizers that can significantly reduce protein aggregation and stabilize proteins during storage. These stabilizers offer a promising alternative to conventional polysorbate surfactants.
Polysorbates are commonly used in biologic formulations to prevent particle formation; however, polysorbates themselves are known to degrade and this can produce adverse reactions in patients, such as an immune response. By substituting ReForm’s stable surfactant replacements for polysorbates in biologic formulations, biopharmaceutical companies can reduce protein aggregation and ultimately improve patient care. This patent adds further protection to ReForm’s stabilizer platform, as they build a portfolio of new excipients for use in biotherapeutic formulations.
“Potential immune responses in patients associated with protein aggregation have become a major concern for regulatory agencies and for innovator and biosimilar companies seeking approval of biotherapeutics,” said John M. Sorvillo, PhD, Chief Executive Officer. “We believe that the use of these new surfactant replacements in the ‘048 patent can allow biopharmaceutical companies to differentiate their formulations, and more importantly, can provide patients safer drug formulations.”