Human medical treatment by aerosol inhalation of immunoglobulin A
View Patent ↗Pooled human plasma is processed by cold ethanol fractionation to produce purified immunoglobulin G antibodies for intravenous administration. Immunoglobulin A is an unwanted by-product since intravenous administration of immunoglobulin A-containing immunoglobulin G can cause life-threatening anaphylaxis in some people. The present invention is the topical application of immunoglobulin A coupled with J chain, and optionally coupled with secretory component in order to render the immunoglobulin A more physiologically active, for the prevention or treatment of ocular diseases including ocular immune deficiency and infections. Antigen-specific monoclonal immunoglobulin A may be used.
1. A method for producing a therapeutic composition comprising the step of: combining polyclonal monomeric IgA with a recombinant J chain and a recombinant secretory component in a molar ratio of the IgA to the J chain of 2:1 and a molar ratio of an IgA-J chain conjugate to the secretory component of 1:1, wherein the recombinant J chain and secretory components are sequentially combined with the polyclonal monomeric IgA, and wherein the polyclonal monomeric IgA comprises a by-product of cold ethanol fractionation of pooled plasma derived from more than one human individual, wherein the by-product is prepared by:
providing pooled human plasma;
fractionating the pooled human plasma to produce a polyclonal monomeric IgA rich fraction;
adsorbing the polyclonal monomeric IgA rich fraction onto an ion exchange medium to form a bound portion of the polyclonal monomeric IgA;
recovering the bound portion of the polyclonal monomeric IgA;
subjecting the recovered bound portion of the polyclonal monomeric IgA to antiviral treatment; and
sterilizing the resulting product.
2. The method according to claim 1 , wherein the pooled human plasma is derived from specifically immunized donors.
3. A method for producing a therapeutic composition comprising the step of: combining monoclonal monomeric IgA, a recombinant J chain, a recombinant secretory component, wherein the J chain and secretory components are sequentially combined with the monoclonal monomeric IgA after production of the monoclonal monomeric IgA by hybridoma techniques.
4. The method of claim 3 wherein the recombinant J chain is humanized.
5. The method of claim 3 wherein the IgA is present at a concentration of 5 milligrams per dose.
6. The method of claim 3 wherein the IgA is conjugated to the recombinant J chain by a disulfide linkage.
7. The method of claim 3 further comprising the step of adding a pharmaceutical excipient.
8. The method of claim 3 further comprising the step of adding a buffering agent.
9. The method of claim 3 wherein the IgA is conjugated to the recombinant secretory component by a disulfide linkage.