Abstract
The hepatitis B vaccine which is commercially available in the United States consists of noninfectious hepatitis B surface antigen (HBsAg) which is purified from the plasma of asymptomatic chronic carriers of the hepatitis B virus (1,2,3). The excess HBsAg subunit present in large quantities in the plasma of these individuals first is separated from the heavier hepatitis B virus and from extraneous blood proteins by two ultracentrifugation steps. It then is subjected sequentially to three chemical treatments (pepsin at pH 2, 8M urea and formaldehyde) to insure killing of any residual hepatitis B virus as well as any other infectious agent which might be present in human plasma. The vaccine manufacturing facility provides total physical separation of each of the critical inactivation steps and prevents introduction of untreated materials into later process steps. All chemical reagents are assayed for potency before and after use to insure proper inactivation at each of the steps. All lots of vaccine are extensively tested for purity, potency and safety, including a test for safety in susceptible chimpanzees.
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McLean, A.A., Buynak, E.B., Kuter, B.J., Hilleman, M.R., West, D.J. (1984). Clinical Experience with Hepatitis B Vaccine. In: Millman, I., Eisenstein, T.K., Blumberg, B.S. (eds) Hepatitis B. Springer, Boston, MA. https://doi.org/10.1007/978-1-4899-0369-3_12
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DOI: https://doi.org/10.1007/978-1-4899-0369-3_12
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