Patent ID: 6967106

Claim:
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.