Biologic and method of preparing same

Claim 1

A method of treating a mammal in order to increase the Natural Killer cell population thereof, said method comprising the step of administering by injection to the mammal a biologic, said biologic being produced by the method of: (1) injecting a feline panleukopenia or canine origin parvovirus into an animal other than a feline or canine, and which is a non-permissive host for the virus; (2) permitting said injected animal to react to the presence of said virus for a period of time of at least one month for developing in the animal's blood serum said biologic such that 50 microliters of the animal's serum, when added to an in vitro human white blood cell culture containing 2-4×10 5 white blood cells and followed by three days incubation at 37° C. under a 5% CO 2/ 95% air atmosphere, will give rise to at least about a 50% increase in T-Helper and Natural Killer cells in the biologic-supplemented cell culture as compared with an otherwise identical and identically cultured in vitro cell culture having added thereto 50 microliters of serum from a normal animal of the same species as said injected animal, such rise in T-Helper and Natural Killer cells being detected by staining with fluorescent-labelled monoclonal antibodies against T-Helper and Natural Killer cells; and (3) recovering blood from said injected animal containing said biologic, and fractionating the recovered blood serum or plasma removed from the red blood cells, with the in vitro assay being performed on each separated fraction, in order to insure or determine that the biologic is retained throughout, by the selection of only positive serum or plasma fractions to separate potentially interfering substances from the biologic.

Claim 2

A method of treating a mammal in order to increase the Natural Killer cell population thereof, said method comprising the step of administering by injection to the mammal a biologic, said biologic being produced by the method of: (1) injecting a feline panleukopenia or canine origin parvovirus into an animal other than a feline or canine, and which is a non-permissive host for the virus; (2) permitting said injected animal to react to the presence of said virus for a period of time of at least one month for developing in the animal's blood serum said biologic such that 50 microliters of the animal's serum, when added to an in vitro human white blood cell culture containing 2-4×10 5 white blood cells and followed by three days incubation at 37° C. under a 5% CO 2/ 95% air atmosphere, will give rise to at least about a 50% increase in T-Helper and Natural Killer cells in the biologic-supplemented cell culture as compared with an otherwise identical and identically cultured in vitro cell culture having added thereto 50 microliters of serum from a normal animal of the same species as said injected animal, such rise in T-Helper and Natural Killer cells being detected by staining with fluorescent-labelled monoclonal antibodies against T-Helper and Natural Killer cells; and (3) recovering blood from said injected animal containing said biologic, and fractionating the recovered blood serum or plasma removed from the red blood cells, with the in vitro assay being performed on each separated fraction, in order to insure or determine that the biologic is retained throughout, by the selection of only positive serum or plasma fractions to separate potentially interfering substances from the biologic.