Elimination of serum proteins and potential virus contaminants during hepatitis B vaccine preparation.
As first generation hepatitis B vaccines are derived from human plasma, detailed information is required concerning the elimination of hepatitis B virus and other potential transmissible infectious agents during vaccine preparation. To demonstrate the safety of a hepatitis B vaccine, the efficiency of each of the six main steps used in the preparation process to remove or destroy pathogens was determined for representatives of major groups of animal viruses. Infectivity of all the tested viruses was reduced 10(5)-fold to a factor of 10(9)-fold by the first and last steps, namely PEG fractionation and formalin treatment. The four successive zonal ultracentrifugations decreased virus infectivity by at least 10(7)-fold. Five of these steps tend also to purify the hepatitis B surface antigen (HBsAg) which increases the HBsAg: protein ratio by at least 10(5)-fold. Considering the high degree of purity obtained, checked on each batch, it is concluded that the procedure consistently eliminates any potential virus with a ide safety margin.
D001798:Blood Proteins / Q000302:isolation & purification*; D005591:Chemical Fractionation; D004340:Drug Contamination / Q000517:prevention & control*; D005557:Formaldehyde / Q000494:pharmacology; D006514:Hepatitis B Surface Antigens / Q000302:isolation & purification; D017325:Hepatitis B Vaccines; D014461:Ultracentrifugation; D014761:Viral Hepatitis Vaccines; D014780:Viruses
D001798:Blood Proteins; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D014761:Viral Hepatitis Vaccines; D005557:Formaldehyde