US2020087390A1PendingUtilityA1

Anti-tnf alpha antibody formulations

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Assignee: AMGEN INCPriority: Dec 21, 2016Filed: Dec 20, 2017Published: Mar 19, 2020
Est. expiryDec 21, 2036(~10.4 yrs left)· nominal 20-yr term from priority
Inventors:William J. CallahanRahul Rajan KaushikJoy Brennan
A61K 9/08A61K 47/10A61K 47/183A61K 9/0019A61K 39/39591C07K 16/241
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Claims

Abstract

Stable adalimumab formulations are disclosed.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A stable aqueous formulation comprising about 180 mg/mL adalimumab, about 20 mM glutamate, and about 160 mM monoethanolamine (MEA), wherein the formulation has a pH of about 5.2, and demonstrates less than about a 2.1-fold increase in acidic species as measured by cation-exchange high-performance liquid chromatography (CEX-HPLC) after storage for 28 days at 40° C.

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