Methods and compositions for production and purification of recombinant staphylococcal enterotoxin b (rseb)

Abstract

The invention provides processes and compositions for fermentation, recovery and purification of recombinant bacterial superantigens (rSAgs), exemplified by a recombinant staphylococcal enterotoxin B SEB protein mutated for use in administration to mammalian recipient. This process generates an economically viable quantity of rSEB vaccine protein meeting FDA parenteral drug specifications. The purification methods generally involve multiple steps including hydrophobic interaction chromatography (HIC), buffer exchange (desalting), and cation exchange. The final product of the purification is a highly purified rSAg composition satisfying clinical safety criteria and is immunogenic and protective against lethal aerosol challenge in a murine model. The methods and compositions of the invention provide useful tools for treatment of disease and other conditions caused by bacterial SAgs, including food poisoning, bacterial arthritis and other autoimmune disorders, toxic shock syndrome, and insults attributed to the potential use of SAg biowarfare agents.

Dependencies are inferred from the claim text.