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Last Updated: January 26, 2022

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Claims for Patent: 9,821,059

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Summary for Patent: 9,821,059
Title:Composition for stabilizing protein and pharmaceutical formulation comprising the same
Abstract: The present invention relates to a composition for stabilizing TNF.alpha.-binding protein exhibiting physiological activity, and more specifically, to a composition for stabilizing protein including basic amino acid and sugar and/or ammonium salt, a pharmaceutical formulation including the same, and a method for stabilizing TNF.alpha.-binding protein. The formulation including basic amino acid; and sugar and/or ammonium salt according to the present invention effectively inhibits aggregation, denaturation and oxidation of TNF.alpha.-binding protein used for treating various diseases, for example, an anti-TNF-alpha antibody, such that the protein is capable of being preserved and stored for a long time, which is widely usable and effective in a medical field using TNF.alpha.-binding protein, for example, an anti-TNF-alpha antibody.
Inventor(s): Park; Soon Jae (Daejeon, KR), Chung; Hye-Shin (Daejeon, KR), Kim; Jin Hwan (Daejeon, KR), Byun; Minsoo (Daejeon, KR), Yeon; Ji Hyeon (Daejeon, KR)
Assignee: ALTEOGEN INC. (Daejeon, KR)
Application Number:14/884,312
Patent Claims:1. A stabilized adalimumab composition, comprising: adalimumab; arginine with a concentration of 50 to 100 mM; mannitol with a concentration of 1 to 2.5% (w/v); ammonium sulfate with a concentration of 40-65 mM; and citric acid.

2. The composition according to claim 1, pH of the composition is 5.7 to 6.3.

3. The composition according to claim 1, comprising 5 to 100 mg/ml of adalimumab.

4. The composition according to claim 1, wherein the stabilization is one selected from the following (a) to (e): (a) inhibition of denaturation, deamidation or oxidation of adalimumab; (b) inhibition of reduction of K0 variants (the major peak in HPLC of lysine variants of monoclonal antibody) of C-terminal lysine; (c) inhibition of production of acidic variants; (d) inhibition of reduction ratio of adalimumab monomer; and (e) inhibition of aggregation of adalimumab or inhibition of increase in production of fragments thereof.

5. A pharmaceutical formulation comprising a composition according to claim 1.

6. A method of stabilizing adalimumab comprising adding arginine, mannitol, ammonium sulfate and citric acid to a solution containing adalimumab, wherein a concentration of arginine in the solution is 50 to 100 mM, a concentration of mannitol is 1 to 2.5% (w/v) and a concentration of ammonium sulfate is 40-65 mM.

Details for Patent 9,821,059

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 2002-12-31 ⤷  Sign up for a Free Trial 2034-10-17
Abbvie Inc. HUMIRA adalimumab Injection 125057 2008-02-21 ⤷  Sign up for a Free Trial 2034-10-17
Abbvie Inc. HUMIRA adalimumab Injection 125057 2013-04-24 ⤷  Sign up for a Free Trial 2034-10-17
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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