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US 11,229,702 B1Granted
High concentration formulations of adalimumab
AssigneeCoherus Biosciences, Inc.
InventorsMark Manning, Ryan Erik Holcomb
Life of this patent
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Abstract
The present invention relates to aqueous pharmaceutical compositions comprising a high concentration (i.e., greater than 50 milligrams per milliliter) of adalimumab (including antibody proteins considered or intended as “biosimilar” or “bio-better” variants of commercially available adalimumab) suitable for long-term storage, and methods of manufacture of the compositions; methods of their administration; and articles containing the same.
Claims15
A stable aqueous pharmaceutical composition comprising:
- a concentration of adalimumab greater than about 50 mg/mL and less than or equal to about 200 mg/mL;
- and
- ionic excipients, wherein the ionic excipients comprise about 10 mM to 50 mM of histidine, about 13 mM to 140 mM of NaCl, and about 90 mM to 240 mM of glycine, wherein the ionic excipients contribute to the composition having conductivity greater than 2.5 mS/cm;
- wherein the composition has:
- an osmolarity of about 140 to about 400 mOsm/L;
- a pH of about 5 to about 6;
- and a viscosity equal to or less than about 20 cP, and
- the composition is stable for two weeks at 40° C., and for four weeks at 25° C.
5 more elements
Dependencies are inferred from the claim text.