US 11,780,906 B2
Compositions and methods for the treatment of immunodeficiency
Adam S. Grossman, Saddle River, NJ (US); James Mond, Silver Spring, MD (US); Jerrold B. Grossman, Saddle River, NJ (US); and Dov A. Goldstein, New York, NY (US)
Assigned to ADMA BIOMANUFACTURING, LLC, Boca Raton, FL (US)
Filed by ADMA Biologics, Inc., Ramsey, NJ (US)
Filed on May 23, 2022, as Appl. No. 17/750,470.
Application 17/750,470 is a continuation of application No. 16/901,993, filed on Jun. 15, 2020, granted, now 11,339,206.
Application 16/901,993 is a continuation of application No. 15/978,692, filed on May 14, 2018, granted, now 10,683,343, issued on Jun. 16, 2020.
Application 15/978,692 is a continuation of application No. 15/811,486, filed on Nov. 13, 2017, granted, now 9,969,793, issued on May 15, 2018.
Application 15/811,486 is a continuation of application No. 14/592,727, filed on Jan. 8, 2015, granted, now 9,815,886, issued on Nov. 14, 2017.
Claims priority of provisional application 62/069,589, filed on Oct. 28, 2014.
Prior Publication US 2022/0403008 A1, Dec. 22, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/395 (2006.01); C07K 16/06 (2006.01); A61K 39/42 (2006.01); C07K 16/08 (2006.01); C07K 16/10 (2006.01); A61K 39/155 (2006.01); A61K 45/06 (2006.01); G01N 33/68 (2006.01); C07K 16/12 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/06 (2013.01) [A61K 39/155 (2013.01); A61K 39/39516 (2013.01); A61K 39/42 (2013.01); A61K 45/06 (2013.01); C07K 16/08 (2013.01); C07K 16/10 (2013.01); C07K 16/1009 (2013.01); C07K 16/1027 (2013.01); C07K 16/1203 (2013.01); C07K 16/1232 (2013.01); C07K 16/1242 (2013.01); C07K 16/1271 (2013.01); C07K 16/1275 (2013.01); C07K 16/1282 (2013.01); C07K 16/1285 (2013.01); C07K 16/1289 (2013.01); G01N 33/6854 (2013.01); A61K 2039/507 (2013.01); C07K 2317/10 (2013.01); C07K 2317/21 (2013.01); C07K 2317/31 (2013.01); C07K 2317/76 (2013.01); Y02A 50/30 (2018.01)] 20 Claims
 
1. A method of providing immunotherapy to a subject comprising administering to the subject an immunotherapeutic composition comprising:
A) immune globulin prepared from a pooled plasma composition comprising plasma samples from 500 or more human plasma donors, wherein the pooled plasma composition has a final respiratory syncytial virus (RSV) neutralization titer of at least 1800, and an antibody titer for parainfluenza virus 1, parainfluenza virus 2, influenza A virus, and/or influenza B virus that is at least 1.3 times greater than the antibody titer in a control sample, wherein the control sample is a mixture of plasma samples obtained from 500 or more random human plasma donors, and wherein less than 50% of the donor plasma samples used for pooling are from donors with a RSV neutralization titer of at least 1800; and
B) a pharmaceutically acceptable carrier;
wherein the immunotherapeutic composition is intravenously administered in a single dose to provide between 250-2500 milligram (mg) immune globulin per kilogram (kg) to the subject.