PROCESS FOR PREPARATION OF SECRETORY IgA AND SECRETORY IgM

Abstract

A process for synthesizing and separating secretory IgA from a mixture of IgA monmer and IgA dimer is provided. The process includes covalently binding affinity tagged or epitope tagged recombinant secretory component to the IgA dimer in the mixture and binding the affinity tagged or an epitope tagged secretory IgA to immobilized moieties on the solid phase support resin to which the affinity tag or epitope tag binds and then eluting the affinity tagged or an epitope tagged secretory IgA with release buffer. A process for synthesizing and separating secretory IgM from a mixture of IgM and other plasma proteins is also provided. The process includes covalently binding affinity tagged or an epitope tagged recombinant secretory component to the IgM in the mixture and binding the affinity tagged or an epitope tagged secretory IgM to immobilized moieties on the solid phase support resin and then eluting the peptide tagged secretory IgM with a release buffer.

Description

RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 13 / 935,417; filed Jul. 3, 2013; and a continuation-in-part of PCT application Serial No. PCT / EP2013 / 054697 filed Mar. 8, 2013 that in turn claims priority benefit of EP 12158931.1 filed Mar. 9, 2012 and EP 12168343.7 filed May 16, 2012; the contents of which are hereby incorporated by reference.FIELD OF THE INVENTION[0002]This invention relates in general to a process for the preparation of secretory IgA and secretory IgM from plasma proteins containing IgA and / or IgM, and in particular to a process that is scalable to allow the production of commercial quantities of medicaments containing the same.BACKGROUND OF THE INVENTION[0003]Clostridium difficile (C. difficile) is a gram-positive anaerobic bacillus. Disease is associated with C. difficule infection.[0004]Antibiotic associated pseudomembranous colitis results from the use of broad-spectrum antibiotic agents such as clindamycin. Thes...

AI Technical Summary

Benefits of technology

The patent describes a process for making secretory IgA and permeasing it from other substances like proteins. This is important because it involves using an affinity tag or epitope tag to capture the desired product. The process involves applying a modified secretory component to a resin, washing away unwanted substances, and then using a release agent to elude the desired product. The use of a new composition that includes a histidine tag makes this process easier.

Problems solved by technology

These drugs result in further disruption of the intestinal flora and are associated with a 20-25% incidence of disease relapse.

The isolation of secretory forms of immunoglobulins is more difficult that securing forms of a respective immunoglobulin that circulate in the blood and lack secretory component.

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