Compositions and methods for the treatment of immunodeficiency
AssigneeAdma Biomanufacturing, LLC
InventorsAdam S. Grossman, James Mond, Jerrold B. Grossman, Dov A. Goldstein
Life of this patent
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Abstract
The present invention relates to compositions and methods for the treatment of immunodeficiency (e.g., primary immunodeficiency disease). In particular, the invention provides human plasma immunoglobulin compositions containing select antibody titers specific for a plurality of respiratory pathogens, methods of identifying human donors and donor samples for use in the compositions, methods of manufacturing the compositions, and methods of utilizing the compositions (e.g., for prophylactic administration and/or therapeutic treatment (e.g., passive immunization (e.g., immune-prophylaxis))).
Claims21
1-50. (canceled)
A method of reducing the risk of infection in an immunocompromised subject at risk thereof, comprising prophylactically administering to the subject, before clinical onset of the infection, 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 one or more respiratory pathogens selected from parainfluenza virus 1, parainfluenza virus 2, coronavirus, influenza A virus, influenza B virus, and metapneumovirus 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 an RSV neutralization titer of at least 1800;
- and
- B) a pharmaceutically acceptable carrier;
- wherein the immunotherapeutic composition provides protective levels of circulating antibodies in the subject.
A method of maintaining protective trough levels of circulating antibodies in an immunocompromised subject at risk of infection, the method comprising administering to the subject an immunotherapeutic composition on a recurring dosing schedule, wherein the immunotherapeutic composition comprises:
- 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 RSV neutralization titer of at least 1800, and an antibody titer for one or more respiratory pathogens selected from parainfluenza virus 1, parainfluenza virus 2, coronavirus, influenza A virus, influenza B virus, and metapneumovirus 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 an RSV neutralization titer of at least 1800;
- and
- B) a pharmaceutically acceptable carrier;
- wherein the recurring dosing schedule maintains the protective trough levels between administrations of the immunotherapeutic composition.
Dependencies are inferred from the claim text.