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US 2026/0265366 A1Published application
Risankizumab compositions
AssigneeAbbVie Inc.
InventorsChen WANG, Georgeen GAZA-BULSECO, Johanna Lindermuth GERVAIS, Jie WANG
Life of this patent
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Abstract
The present disclosure relates, in part, to risankizumab compositions having a reduced level of hitchhiker protein PLA2, Poloxamer 188, and/or decreased immunogenicity.
Claims20
A composition comprising:
- (a) risankizumab;
- and
- (b) a surfactant,
- wherein the concentration of surfactant following storage for at least 6 months at 5° C. is at least about 80% of the initial surfactant concentration.
1 more element
A composition comprising:
- (a) risankizumab at a concentration of 150 mg/mL, and
- (b) a surfactant,
- wherein at least 99.1% of the risankizumab is present as a monomer and/or no more than about 0.4% of risankizumab is present as high molecular weight (HMW) species as measured by ultra-performance size exclusion chromatography (UP-SEC).
A method of increasing long-term storage stability of a liquid aqueous composition comprising risankizumab.
A process for producing a risankizumab drug product having risankizumab with a high mannose N-glycan in an amount that is less than about 5.4% of total risankizumab species with N-glycosylation, the process comprising:
- (1) culturing a host cell line expressing risankizumab in a growth medium under conditions that permit production of risankizumab;
- (2) clarifying the growth medium by centrifugation and depth filtration;
- (3) contacting the clarified medium containing risankizumab with a Protein A resin;
- (4) eluting risankizumab from the protein A resin to obtain a first eluate;
- (5) filtering the first eluate through a depth filter;
- (6) contacting the filtered first eluate to a mixed-mode resin to obtain a first flowthrough containing risankizumab;
- (7) contacting the first flow-through to a cation exchange resin;
- (8) eluting risankizumab from the cation exchange resin to obtain a second eluate;
- (9) processing the second eluate by ultrafiltration and diafiltration, thereby obtaining a risankizumab drug product having risankizumab with a high mannose N-glycan in an amount that is less than about 5.4% of total risankizumab species with N-glycosylation.
6 more elements
Dependencies are inferred from the claim text.