Removal of hepatitis B virus infectivity from human gamma-globulin prepared by ion-exchange chromatography.
Hepatitis B virus infectivity can be removed from human plasma used to prepare a gamma-globulin product by ion-exchange chromatography with commercially available resins. A pooled human plasma sample free of hepatitis markers was contaminated with 10,000 chimpanzee infectious doses of hepatitis B virus per milliliter from a known infectious inoculum. The contaminated plasma was diluted to yield a weakly positive radioimmunoassay result for HBsAg and then processed over a double-column chromatography system containing anionic ion-exchange resins to yield highly purified gamma-globulin. Two chimpanzees were each inoculated intravenously with this product while a control animal received non-treated material. The 2 experimental animals each received a potential challenge of 3,000 ID and showed no serologic evidence of the disease during 9 months of evaluation. The control animal received 100 ID and developed hepatitis B 25 weeks after the challenge.
R P
RP
Zolton
J V
JV
Padvelskis
P M
PM
Kaplan
D000818:Animals; D002852:Chromatography, Ion Exchange; D004340:Drug Contamination / Q000517:prevention & control*; D005260:Female; D006509:Hepatitis B / Q000209:etiology / Q000517:prevention & control; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D002679:Pan troglodytes; D012449:Safety; D005719:gamma-Globulins / Q000009:adverse effects* / Q000302:isolation & purification
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D005719:gamma-Globulins