ABSTRACT

The antigenic components of Hexavac are produced and purified separately and combined into the final product. Diphtheria toxoid is obtained from a culture of Corynebacterium diphtheriae, detoxified using formalin, and purified by salt precipitation. Tetanus toxoid is obtained from a Clostridium tetani culture, detoxified with formalin, and purified by ammonium sulphate precipitation. Pertussis antigens, pertussis toxin, and filamentous hemagglutinin are obtained from a culture of Bordetella pertussis; pertussis toxin is treated with glutaraldehyde for detoxification, while filamentous hemagglutinin is used in its native form. The surface hepatitis B antigen is produced in a genetically modified Saccharomyces cereυisiae strain by recombinant DNA technology. Purification includes chromatographic steps f or removal of yeast

potency, and safety of the vaccine.