New class of excipients offers a promising alternative to
polysorbates for stabilizing proteins
WOBURN, Mass.–(BUSINESS WIRE)–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
Contacts
Rob Kloppenburg
Shoreline Biotech Communications
(617) 930-5595