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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