Process for making novel blood clotting enzyme compositions

a method for inactivating hepatitis A virus in a blood clotting enzyme composition suspected to contain hepatitis A virus, which method for inactivating hepatitis A virus consists essentially of heating the composition in the dry state until the composition is substantially free of said virus in the infectious form and said blood clotting enzyme in the denatured form.

A method for inactivating hepatitis B virus in a blood clotting enzyme composition suspected to contain hepatitis B virus, which method for inactivating hepatitis virus consists essentially of heating the composition in the dry state until the composition is substantially free of said virus in the infectious form and said blood clotting enzyme in the denatured form.

A method for inactivating non-A, non-B hepatitis virus in a blood clotting enzyme composition suspected to contain non-A, non-B hepatitis virus, which method for inactivating non-A, non-B hepatitis virus consists essentially of heating the composition in the dry state until the composition is substantially free of said virus in the infectious form and said blood clotting enzyme in the denatured form.

A method for making a control or standard from blood plasma containing an infective virus, comprising removing substantially all reducing sugars from the plasma, lyophilizing the plasma and heating the lyophilized plasma until the plasma is substantially free of said virus in the infectious form and said blood clotting enzyme in the denatured form.

A method for inactivating virus in a composition which contains antihemophilic factor and at least one blood clotting enzyme, and which is suspected to contain an infective virus, which method for inactivating consists essentially of heating the composition in the dry state until the composition is substantially free of said virus in the infectious form and said blood clotting enzyme in the denatured form.

A method for treating a dry composition containing a blood clotting enzyme purified about from 3 to 50 fold over the concentration of such enzyme in normal human plasma. and suspected to contain an infective virus, which method comprises heating the composition in the dry state until the composition is substantially free of said virus in the infectious form and said blood clotting enzyme in the denatured form.

In a method wherein a therapeutically effective amount of a blood clotting enzyme is infused into a patient, the improvement comprising infusing into said patient a composition containing noninfectious virus and a therapeutically effective amount of said enzyme, which composition is substantially free of said virus in the infectious form and substantially free of said enzyme in the denatured form.

A method for inactivating virus in a composition comprising at least one blood clotting enzyme in a therapeutically effective amount, which method comprises heating the composition in the dry state until the composition is substantially free of said virus in the infectious form and said blood clotting enzyme in the denatured form.

A composition containing noninfectious virus and at least one human blood clotting enzyme, said virus having been made noninfectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form, is substantially free of said blood clotting enzyme in the denatured form and which contains viral residues which are partially immunologically cross-reactive with the infectious virus.

A composition containing noninfectious hepatitis A virus having been made noninfectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form, is substantially free of said blood clotting enzyme in the denatured form and which contains viral residues which are partially immunologically cross-reactive with hepatitis A infectious virus.

A composition containing noninfectious hepatitis B virus and at least one blood clotting enzyme, said virus having been made noninfectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form, is substantially free of said blood clotting enzyme in the denatured form and which contains viral residues which are partially immunologically cross-reactive with hepatitis B infectious virus.

A composition containing noninfectious non-A, non-B hepatitis virus and at least one blood clotting enzyme, said virus having been made noninfectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form, is substantially free of said blood clotting enzyme in the denatured form and which contains viral residues which are partially immunologically cross-reactive with non-A, non-B hepatitis virus.

A composition containing noninfectious virus, antihemophilic factor and at least one blood clotting enzyme, said virus having been made noninfectious by a method consisting essentially of heating the virus until the virus is inactivated, which composition is substantially free of said virus in the infectious form and said blood clotting enzyme and antihemophilic factor in the denatured form.

A composition containing noninfectious virus and at least one blood clotting enzyme in a purification of about from 3- to 50-fold over the concentration of such enzyme in normal human plasma, which composition is substantially free of said virus in the infectious form and said enzyme in the denatured form.

A composition comprising noninfectious virus and a therapeutically effective amount of at least one blood clotting enzyme, said composition being substantially free of said virus in the infectious form and substantially free of said blood clotting enzyme in the denatured form.