Method for production and purification of hepatitis b vaccine

C - Chemistry – Metallurgy – 12 – P

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167/129, 530/15.

C12P 21/02 (2006.01) A61K 39/29 (2006.01) C07K 14/02 (2006.01) C12N 15/85 (2006.01)

Patent

CA 2026570

Processes are provided for producing purified, hepatitis B surface antigen particles in mammalian cells which comprise culturing mammalian cells which produce the particles in a culture medium supplemented with a serum free of high molecular weight contaminant proteins and recovering the purified, hepatitis B surface antigen particles. Removal of molecules having a molecular weight greater than about 3 x 10 5 daltons by prefractionation, for example, allows cells to be grown in culture media containing high levels of fetal calf serum, removes high molecular weight contaminant proteins which may be inhibitory to cell growth and simplifies purification of HBsAg since high molecular weight contaminant proteins are the major contaminants removed by purification processes.

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