Anaerobic process for production of a gel-adsorbed anthrax immunizing antigen

Claim 1

A METHOD OF PREPARING A NONVIABLE ANTBRAX IMMUNIZING ANTIGEN SUITABLE FOR USE IN HUMAN IMMUNIZATION WHICH COMPRISES PREPARING A NON-PROTEIN, CHEMICALLY DEFINED MEDIUM COMPRISING A READILY UTILIZABLE CARBOHYDRATE, AMINO ACIDS AND MAGNESIUM, CALCIUM, FERROUS AND MANGANOUS INORGANIC SALTS, STERILIZING THE MEDIUM BY AUTOCLAVING, ADDING STERILE BICARBONATE SOLUTION TO THE STERILIZED MEDIUM, INOCULATING SAID MEDIUM WITH A SELECTED SPORE SUSPENSION OF BACILLUS ANTHRACIS, CULTURING UNDER ANAEROBIC CONDITIONS AT ABOUT 37*C. UNTIL THE GROWTH FORMS A TURBID SUSPENSION, ADJUSTING THE PH OF THE MEDIUM TO ABOUT 8.0 TO 8.1, FILTERING OUT THE ORGANISMS, ADDING TO THE FILTRATE A STERILE SOLUTION OF PREFORMED ALUMINUM HYDROXIDE GEL, READJUSTING THE PH TO ABOUT 8.0 TO 8.1, ALLOWING THE RESULTING GEL SOLUTION TO SETTLE, REMOVING AND DISCARDING THE SUPERNATANT, RENDERING THE REMAINING GEL FLUID BY ADDING STERILE PHYSIOLOGICAL SALINE AND STABILIZING THE RESULTING ANTIGEN BY ADDING STERILE SOLUTIONS OF BENZETHONIUM CHLORIDE AND FORMALDEHYDE.

Claim 2

A METHOD OF PREPARING A NONVIABLE ANTBRAX IMMUNIZING ANTIGEN SUITABLE FOR USE IN HUMAN IMMUNIZATION WHICH COMPRISES PREPARING A NON-PROTEIN, CHEMICALLY DEFINED MEDIUM COMPRISING A READILY UTILIZABLE CARBOHYDRATE, AMINO ACIDS AND MAGNESIUM, CALCIUM, FERROUS AND MANGANOUS INORGANIC SALTS, STERILIZING THE MEDIUM BY AUTOCLAVING, ADDING STERILE BICARBONATE SOLUTION TO THE STERILIZED MEDIUM, INOCULATING SAID MEDIUM WITH A SELECTED SPORE SUSPENSION OF BACILLUS ANTHRACIS, CULTURING UNDER ANAEROBIC CONDITIONS AT ABOUT 37*C. UNTIL THE GROWTH FORMS A TURBID SUSPENSION, ADJUSTING THE PH OF THE MEDIUM TO ABOUT 8.0 TO 8.1, FILTERING OUT THE ORGANISMS, ADDING TO THE FILTRATE A STERILE SOLUTION OF PREFORMED ALUMINUM HYDROXIDE GEL, READJUSTING THE PH TO ABOUT 8.0 TO 8.1, ALLOWING THE RESULTING GEL SOLUTION TO SETTLE, REMOVING AND DISCARDING THE SUPERNATANT, RENDERING THE REMAINING GEL FLUID BY ADDING STERILE PHYSIOLOGICAL SALINE AND STABILIZING THE RESULTING ANTIGEN BY ADDING STERILE SOLUTIONS OF BENZETHONIUM CHLORIDE AND FORMALDEHYDE.