TH4420B - Hepatitis B vaccine freeze-dried under reduced pressure (process). - Google Patents

Abstract

The preparation of a dry hepatitis B vaccine containing purified hepatitis B virus surface antigen, obtained from recombinant microorganisms capable of producing HBs antigen, and adsorbed onto an aluminum gel and freeze-dried while containing a stabilizer, can be done by the following steps: adding the aluminum gel and stabilizer to the purified recombinant HBs antigen, and then freeze-drying the mixture under pressure. The resulting dry product can be stored stably for extended periods without losing the antigen titer and is highly useful for preventing hepatitis B virus infection.

Claims (9)

1. Preparation of hepatitis B vaccine by freeze-drying (lyophilization) containing purified hepatitis B virus surface antigen prepared from recombinant yeast capable of producing HBs antigen. This antigen is adsorbed onto an aluminum gel and then freeze-dried under pressure with a stabilizer present. The lyophilized preparation is done by adding the aluminum gel and stabilizer to the purified HBs antigen from the recombinant yeast source and then freeze-drying the mixture under pressure. 2. The preparations described in Reputation 1, whereby the aluminum gel used is aluminum hydroxide gel or aluminum phosphate gel. 3. Such preparation as described in claim 1, whereby the stabilizer is selected from a group of amino acids, or their salts, or saccharides. 4. Such preparation as described in claim 3 contains at least one amino acid or its salt, or at least one saccharide. 5. Such preparation as described in claim 3, whereby the stabilizer used consists of a mixture of at least one amino acid or its salt with at least one saccharide or with at least one colloid. 6. Such preparations as described in claim 4 shall use amino acids or their salts selected from the group comprising glycine, alanine, monosodium glutamate, arginine, and lysine, and saccharides selected from the group comprising glucose, xylose, galactose, fructose, lactose, maltose, saccharose, mannitol, sorbitol, and xylitol. 7. Such preparations as described in claim 5 are made using amino acids or their salts: glycine, alanine, monosodium glutamate, arginine, or lysine; saccharides: glucose, xylose, galactose, fructose, lactose, maltose, saccharose, mannitol, sorbitol, and xylitol; or colloidal substances: gelatin, human albumin, or dextran. 8. The procedure for preparing freeze-dried hepatitis B vaccine involves adding aluminum gel and a stabilizer to a solution of purified hepatitis B virus surface antigen, prepared from griecombinant yeast capable of producing HBs antigen. The mixture containing the hepatitis B vaccine surface antigen adsorbed onto the aluminum gel is then divided into minimum usage units (VUUsers), and each VUUser's mixture is freeze-dried under reduced pressure. 9. The process described in claim 8, whereby the pressure-reducing drying process consists of three steps: pre-lyosylization at low temperature under atmospheric pressure for several hours; initial lyophilization at a higher temperature under pressure reduction for 10 hours or more; and a second lyophilization at an increased temperature under further pressure reduction for several hours to 10 hours.