Method of Antigen-Binding Protein Production
AssigneeAmgen Inc.
InventorsElaheh Binabaji, Chio Mui Chan, Hadley Krizner, Junfen Ma, Diana Woehle
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Abstract
The present disclosure relates to methods of re-oxidizing an antigen-binding protein.
Claims29
A method of re-oxidizing a therapeutic protein comprising at least one di-sulfide bridge, said method comprising:
- (a) subjecting a load composition comprising the therapeutic protein to an affinity chromatography column or membrane;
- and
- (b) washing the affinity chromatography column or membrane with a solution comprising a redox agent at a concentration ranging from 2 μM to 50 μM to produce a flow-through composition, wherein a decreased level of partially-reduced therapeutic protein species is present in the flow-through compared to the load composition.
10-12. (canceled)
The method of claim 12, wherein the load composition is incubated for 1-3 days at a temperature of approximately 2 to 8° C. and wherein the washing conditions in part (b) are conditions sufficient to achieve at least partial re-oxidation of the therapeutic protein.
16-27. (canceled)
The method of claim, further comprising the step of freezing and thawing the load composition prior to the incubating step.
A method of re-oxidizing a therapeutic protein comprising at least one di-sulfide bridge, said method comprising:
- (a) subjecting a load composition comprising the therapeutic protein to an affinity chromatography column or membrane;
- and
- (b) washing the affinity chromatography column or membrane with a solution comprising a redox agent at a concentration ranging from 2 μM to 50 μM to produce a flow-through composition, wherein a decreased level of partially-reduced therapeutic protein species is present in the flow-through compared to the load composition, wherein the therapeutic protein is an antibody comprising a set of 6 CDRs set forth in SEQ ID NOs:
- 3-8.
Dependencies are inferred from the claim text.