Toxoid, Compositions and Related Methods

摘要

Methods of producing purified clostridial toxin comprising tangential flow filtration, hydrophobic interaction chromatography and anion exchange chromatography are disclosed. These methods provide good yields of C. difficile toxin having a purity of about 90% or greater. Highly purified Clostridial toxins, toxoids (e.g., prepared by inactivating the toxin as disclosed herein) and compositions comprising these toxins and/or toxoids are also disclosed. Methods of using the purified toxins and/or toxoids for example, to elicit an immune response against Clostridium (e.g., C. difficile) are also disclosed.

主权项

1. A method for the production of purified C. difficile toxin, the method comprising:
a) applying an impure aqueous solution comprising C. difficile toxin to a hydrophobic interaction support to bind C. difficile toxin thereto; b) eluting the bound C. difficile toxin from the hydrophobic interaction support; c) applying the eluted C. difficile toxin from step (b) to an anion-exchange support selected from the group consisting of: (i) a polymethacrylate resin with quaternary amine functional groups; and (ii) a polyethersulfone membrane with quaternary amine functional groups, to bind C. difficile toxin thereto; and, d) eluting the bound C. difficile toxin from the anion-exchange support.