ReForm Biologics Announces New Patent on Surfactant Replacement Excipients to Stabilize Antibody-Based Therapeutics

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.

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