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Last Updated: March 28, 2024

Claims for Patent: 8,802,828


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Summary for Patent: 8,802,828
Title:High pressure refolding of monoclonal antibody aggregates
Abstract: Methods for refolding antibodies, particularly monoclonal antibodies, from aggregated and/or denatured preparations by subjecting the antibody preparation to high hydrostatic pressure are provided. Refolded preparations of antibodies produced by the methods described herein are also provided.
Inventor(s): Seefeldt; Matthew B. (Denver, CO), Nelson; Robert (Arvada, CO), Randolph; Theodore W. (Niwot, CO), Hesterberg; Lyndal K. (Boulder, CO)
Assignee: Barofold, Inc. (Aurora, CO)
Application Number:13/405,573
Patent Claims:1. A method for refolding a sample of abatacept, comprising the steps of: (a) obtaining an abatacept sample comprising a solution of abatacept exposed to a pH of about 3 and containing from 15% to 21% acid-induced aggregates; (b) adjusting the of the solution to above 5; (c) exposing the abatacept to an increased hydrostatic pressure of about 1000 bar to about 3000 bar for a period of time; and (d) reducing the hydrostatic pressure to atmospheric pressure; wherein the sample of abatacept after exposure to increased hydrostatic pressure has less than about 1% abatacept aggregates than the abatacept sample prior to the increased pressure exposure.

2. The method of claim 1, wherein the content of monomeric and properly folded abatacept is measured by a method selected from a binding assay specific for abatacept, analytical ultracentrifugation, size exclusion chromatography, field flow fractionation, light scattering analysis, light obstruction analysis, fluorescence spectroscopy, gel electrophoresis, gas-phase electrophoretic mobility mass analysis (GEMMA), nuclear magnetic resonance spectroscopy, electron paramagnetic resonance spectroscopy, and reverse-phase chromatography.

3. The method of claim 1 wherein the concentration of abatacept in the abatacept sample is about 0.1 mg/mL to about 10 mg/mL.

4. The method of claim 1 wherein the ionic strength of the abatacept sample is less than about 100 mM.

5. The method of claim 1 wherein the amount of aggregated abatacept present in the abatacept sample alter pressure exposure is 0.8% or less.

Details for Patent 8,802,828

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bristol-myers Squibb Company ORENCIA abatacept For Injection 125118 12/23/2005 ⤷  Try a Trial 2027-09-10
Bristol-myers Squibb Company ORENCIA abatacept Injection 125118 07/29/2011 ⤷  Try a Trial 2027-09-10
Bristol-myers Squibb Company ORENCIA abatacept Injection 125118 06/07/2016 ⤷  Try a Trial 2027-09-10
Bristol-myers Squibb Company ORENCIA abatacept Injection 125118 03/30/2017 ⤷  Try a Trial 2027-09-10
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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