US2018360969A1PendingUtilityA1

Immunoglobulin preparation

57
Assignee: CSL BEHRING AGPriority: Feb 4, 2010Filed: Jun 15, 2018Published: Dec 20, 2018
Est. expiryFeb 4, 2030(~3.6 yrs left)· nominal 20-yr term from priority
A61P 37/00A61K 47/183A61K 9/0019C07K 16/00A61K 47/22A61K 39/39566A61K 39/395
57
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Claims

Abstract

The present invention relates to the use of proline for reducing the viscosity of a protein preparation.

Claims

exact text as granted — not AI-modified
1 .- 20 . (canceled) 
     
     
         21 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises at least 18% immunoglobulin, 100 to 500 mmol/L proline and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, and wherein the preparation has a viscosity of less than 17 mPa·s as measured by a falling ball viscosimeter at 20.0° C. 
     
     
         22 . The syringe of  claim 21 , wherein the immunoglobulin in the preparation consists essentially of IgG obtained from pooled human plasma from at least 1000 donors. 
     
     
         23 . The syringe of  claim 21 , wherein the preparation comprises 250 mmol/L proline. 
     
     
         24 . The syringe of  claim 21 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push. 
     
     
         25 . The syringe of  claim 21 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push. 
     
     
         26 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises at least 18% immunoglobulin consisting essentially of IgG obtained from pooled human plasma from at least 1000 donors, 250 mmol/L proline and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, wherein the preparation has a viscosity of less than 17 mPA·s as measured by a falling ball viscosimeter at 20.0° C., wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push or rapid push. 
     
     
         27 . The syringe of  claim 26 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push. 
     
     
         28 . The syringe of  claim 26 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push. 
     
     
         29 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises 20% to 22% immunoglobulin, 100 to 500 mmol/L proline, and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, and wherein the preparation has a viscosity of less than 19 mPa·s as measured by a falling ball viscosimeter at 20.0° C. 
     
     
         30 . The syringe of  claim 29 , wherein the immunoglobulin in the preparation consists essentially of IgG obtained from pooled human plasma from at least 1000 donors. 
     
     
         31 . The syringe of  claim 29 , wherein the preparation comprises 250 mmol/L proline. 
     
     
         32 . The syringe of  claim 29 , wherein the preparation has a viscosity of less than 17 mPa·s as measured by a falling ball viscosimeter at 20.0° C. 
     
     
         33 . The syringe of  claim 29 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push. 
     
     
         34 . The syringe of  claim 29 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push. 
     
     
         35 . A syringe for subcutaneous administration to a human patient, comprising a liquid immunoglobulin preparation, wherein the preparation comprises 20% to 22% immunoglobulin consisting essentially of IgG obtained from pooled human plasma from at least 1000 donors, 250 mmol/L proline and further comprises polysorbate 80, wherein the preparation has a pH of 4.6 to 5.0, wherein the preparation has a viscosity of less than 19 mPa·s as measured by a falling ball viscosimeter at 20.0° C., wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push or rapid push. 
     
     
         36 . The syringe of  claim 35 , wherein the syringe is configured for subcutaneous administration to a human patient by direct manual push. 
     
     
         37 . The syringe of  claim 35 , wherein the syringe is configured for subcutaneous administration to a human patient by rapid push.

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