DrugPatentWatch Database Preview➤ Subscribe for complete access
« Back to Dashboard
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)|
|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.
|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|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.