Process for disintegrating nucleic acids and preparing biological products of guaranteed quality
AssigneeBaxter Aktiengesellschaft
InventorsFriedrich Dorner, Noel Barrett, Johann Eibl
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Abstract
The invention relates to a method for the disintegration of any biologically active nucleic acid in a biological material, wherein a biologically active material is exposed or multiply exposed to laser beam to disintegrate essentially all biologically active nucleic acid in said biological material, while the biological integrity and activity of said biological material is maintained.
Claims60
A method for disintegrating nucleic acids in a biologically active proteinaceous material that has biological integrity, comprising admixing a phenothiazine photodynamic substance to the biologically active material to form a mixture, and
- exposing the mixture to at least one cycle of irradiation with laser beam light having an intensity of .ltoreq.0.1 J/cm.sup.2 per cycle in order to (i) reduce nucleic acid template activity in the biologically active material by at least a factor of 7 log steps and/or (ii) to reduce the nucleic acid content to less than 100 pg/ml, thereby disintegrating and/or inactivating substantially all biologically active nucleic acid contained in the biologically active material while substantially retaining the biological integrity and activity of the biologically active material.
A method of inactivating viruses comprising
- admixing a phenothiazine photodynamic substance to a virus-containing biological material to thereby form a mixture, and
- exposing the mixture to at least one cycle of irradiation with laser beam light having an intensity of <0.1 J/cm.sup.2 per cycle in order to (i) reduce nucleic acid template activity in the biologically active material by at least a factor of 7 log steps and/or (ii) to reduce the nucleic acid content to less than 100 pg/ml, thereby disintegrating and/or inactivating substantially all biologically active nucleic acid contained in the biologically active material while substantially retaining the biological integrity and activity of the biologically active material.
A method of inactivating non-enveloped viruses in a proteinaceous biological material that has biological integrity, comprising
- admixing a phenothiazine photodynamic substance at a concentration of at least 20 .mu.M to a biological material in order to form a mixture, and
- exposing the mixture to at least 20 cycles of irradiation with a laser beam light in the range of the maximum activation rate of the phenothiazine photodynamic substance, wherein the laser beam light has a light intensity of <0.1 J/cm.sup.2 per cycle.
A virus-inactivated biological material obtainable by inactivating non-lipid-enveloped viruses in a proteinaceous biological material that has biological integrity, wherein the inactivation comprises
- admixing a phenothiazine photodynamic substance to a non-lipid-enveloped virus-containing biological material to thereby form a mixture, and
- exposing the mixture to at least one cycle of irradiation with laser beam light having an intensity of .ltoreq.0.1 J/cm.sup.2 per cycle in order to (i) reduce nucleic acid template activity in the biologically active material by at least a factor of 7 log steps and/or (ii) to reduce the nucleic acid content to less than 100 pg/ml, thereby disintegrating and/or inactivating substantially all biologically active nucleic acid contained in the biologically active material while substantially retaining the biological integrity and activity of biologically active material.
An inactivated virus vaccine obtainable by inactivation of viruses in a proteinaceous biological material that has biological integrity, wherein the inactivation comprises
- admixing a phenothiazine photodynamic substance at a concentration of at least 20 .mu.M to the proteinaceous biological material in order to form a mixture, and
- exposing the mixture to at least 20 cycles of irradiation with a laser beam light in the range of the maximum activation rate of the phenothiazine photodynamic substance, wherein the laser beam light has a light intensity of .ltoreq.0.1 J/cm.sup.2 per cycle.
A method of producing an inactivated virus vaccine, comprising
- admixing a phenothiazine photodynamic substance to a virus-containing biological material to thereby form a mixture,
- exposing the mixture to irradiation with laser beam light having an intensity of .ltoreq.0.1 J/cm.sup.2 per cycle to disintegrate and/or inactivate substantially all biologically active nucleic acid contained in the viruses of the biological material while substantially retaining the antigenicity and immunogenicity of the virus,
- quantitating the nucleic acids in order to determine the level inactivation and/or disintegration of the biologically active nucleic acid in order to obtain a biological material having a quantitated nucleic acid content of less than 100 pg per dose, and
- formulating the inactivated viruses with a physiologically acceptable carrier in order to make the virus vaccine.
Dependencies are inferred from the claim text.