Inactivation of retroviruses in biologicals manufactured for human use.

Human immunodeficiency virus may occur in human plasma and mammalian retroviruses in established cell lines used for the production of monoclonal antibodies or recombinant proteins. To avoid any risk of retrovirus infections being transmitted to human patients by human plasma proteins or other biologicals obtained from established cell lines, these products must be free of contaminating retroviruses. This can be achieved by excluding contaminated source material and by establishing manufacturing procedures which inactivate and eliminate retroviruses.

Results of potency tests of a vaccine against Cl. botulinum type C by different methods.

The potency of vaccine against Cl. botulinum type C was tested comparatively in mice, guinea pigs and mink, using the test methods employed in the United States, Great Britain and Sweden. Additionally the capacity to withstand challenge to toxin in ferrets was investigated.