BaroFold Awarded Patent for Using High Pressure to Improve the Safety
Profile of Biologic Drugs
BaroFold, Inc. today announced it was awarded U.S. Patent No. 8,697,848, entitled “Method for reducing immunogenicity of therapeutic protein compositions,” which provides additional protections over the company’s Pressure Enabled Protein Manufacturing Technology (PreEMT™). PreEMT is being used by BaroFold’s industry partners to improve the tolerability, efficacy and safety of a wide variety of protein therapeutics.
BaroFold’s new patent covers the use of high pressure conditions, such as those in PreEMT, for the substantial reduction of subvisible particulates in a biologic drug in order to reduce the body’s immune response to its administration. These particulates are commonly protein aggregates, which are formed in several traditional methods of manufacturing biologic drugs and result in the formation of neutralizing antibodies that inhibit the drug and may even be life-threatening. Biologics covered by this patent include antibodies, antibody fragments, protein and peptide hormones and enzymes for replacement therapy, among others.
“It is known that subvisible protein aggregates can increase the risk of an immune response to a protein-based therapy, thereby lowering the treatment’s efficacy and increasing safety risks,” said Matthew Seefeldt, Chief Scientific Officer of BaroFold. “This patent issuance validates our partners’ use of PreEMT as a method to improve the safety profiles of novel biologics or biobetters, in addition to making them more rapidly and cost effective.”
BaroFold is applying its Pressure Enabled Protein Manufacturing Technology (PreEMT™) to transform inclusion body refolding and improve the efficacy and safety of a wide variety of protein therapeutics for its industry partners. PreEMT technology has been shown to remove protein aggregates, improving product safety for both new-drug entities and biosimilar products. BaroFold’s contract research services help companies create novel protein therapeutics, accelerate therapeutic protein development, manufacture follow-on biologics, and enable life-cycle management of protein therapeutics. www.barofold.com