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US 9,957,318 B2Granted
Protein purification methods to reduce acidic species
AssigneeAbbVie Inc.
InventorsNatarajan Ramasubramanyan, Lihua Yang, Matthew Omon Herigstad, Hong Yang, Christopher Chumsae
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Abstract
The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the amount of charge variants, aggregates, and fragments of a protein of interest, as well as host cell proteins, present in purified preparations by applying particular chromatography conditions during such protein purification.
Claims30
A method of making a pharmaceutical composition, comprising mixing
- (a) a composition comprising adalimumab, wherein the composition comprises less than 10% total acidic species of adalimumab, wherein the acidic species of adalimumab correspond to the peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab, wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10 mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10 mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5), and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm;
- and
- (b) a pharmaceutically acceptable carrier, thereby making a pharmaceutical composition.
A method of making a pharmaceutical composition, comprising mixing
- (a) a composition comprising adalimumab, wherein the composition comprises less than 10% total acidic species of adalimumab, wherein the acidic species of adalimumab are quantified based on the relative area percent of peaks that elute earlier than the main peak in a WCX-10 HPLC chromatogram of adalimumab wherein the WCX-10 HPLC chromatogram is generated using a first mobile phase of 10 mM Sodium Phosphate dibasic (pH 7.5) and a second mobile phase of 10 mM Sodium Phosphate dibasic, 500 mM Sodium Chloride (pH 5.5) and wherein the WCX-10 HPLC chromatogram is generated using detection at 280 nm;
- and
- (b) a pharmaceutically acceptable carrier comprising a surfactant and a polyalcohol, thereby making a pharmaceutical composition;
- and
- filling a syringe with the pharmaceutical composition.
2 more elements
Dependencies are inferred from the claim text.