New surfactant replacement offers a promising alternative to polysorbates for stabilizing proteins

 

CAMBRIDGE, Mass. – July 11, 2018 – 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. 10,016,513 (the ‘513 patent). The patent, entitled “Stabilizing Excipients for Therapeutic Protein Formulations,” provides ReForm exclusive rights to certain formulations comprising an innovative stabilizer that can significantly reduce protein aggregation and stabilize proteins during storage. This stabilizer offers a promising alternative to conventional polysorbate surfactants.

Polysorbates, the most common surfactants in biologic formulations, are used to prevent therapeutic proteins from adsorbing onto surfaces and interfaces, thereby preventing particle formation. However, polysorbates are known to degrade by hydrolysis, leading to undesirable protein aggregation and surface adsorption. This can produce adverse reactions in patients, such as an immune response to the protein drug. By substituting ReForm’s stable surfactant replacement for polysorbates in biologic formulations, biopharmaceutical companies can reduce protein aggregation and ultimately improve patient care.

“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 ‘513 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, FDA-friendly 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.