New class of excipients offers a promising alternative to polysorbates for stabilizing proteins
WOBURN, Mass. – May 8, 2019 – ReForm Biologics, a pharmaceutical technology company developing innovative biologic formulations to improve drug delivery and manufacturing, 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.”
About ReForm Biologics
ReForm Biologics has developed a technology platform that transforms the formulation of biotherapeutics for the ultimate benefit of patients. Our patented technology can extend product life-cycles, enable alternative dosing, and improve manufacturing efficiency for our biopharmaceutical partners. With multiple industry alliances to date, we offer formulation development collaborations and product-specific licenses for a broad spectrum of protein-based therapeutics.
We don’t make biologics — we make biologics better. www.reformbiologics.com
Shoreline Biotech Communications