Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
3
pubmed:dateCreated
1985-5-16
pubmed:abstractText
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.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Sep
pubmed:issn
0264-410X
pubmed:author
pubmed:issnType
Print
pubmed:volume
2
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
209-14
pubmed:dateRevised
2002-11-1
pubmed:meshHeading
pubmed:year
1984
pubmed:articleTitle
Elimination of serum proteins and potential virus contaminants during hepatitis B vaccine preparation.
pubmed:publicationType
Journal Article