Compositions and methods for producing a viral vaccine with reduced particle size
AssigneeSeqirus UK Limited
InventorsChristopher DADD, Matthew SMITH, Debra LYDIARD
Life of this patent
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Abstract
Disclosed herein are methods and composition producing a viral vaccine with reduced particle size, particularly for use in the production of influenza virus vaccines.
Claims71
A method of producing a viral vaccine formulated in a sub-virion form, the method comprising the steps:
- a. purifying viral particles from harvested cell culture;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising a non-ionic surfactant and an ionic surfactant, and wherein the at non-ionic surfactant and the ionic surfactant is present in an amount effective to reduce particle size of the viral particles.
A method of reducing viral particle size, the method comprising treating the viral particles with a reagent comprising a non-ionic surfactant and an ionic surfactant, and wherein the non-ionic surfactant and the ionic surfactant are present in an amount effective to reduce particle size of the viral particles.
A method of reducing viral particle size in an influenza virus purification process, the method comprising
- a. purifying viral particles harvested from cell culture;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein activating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising a non-ionic surfactant and an ionic surfactant, and wherein the non-ionic surfactant and the ionic surfactant are present in an amount effective to reduce particle size of the viral particles.
A method of producing a viral vaccine formulated in a sub-virion form, the method comprising the steps:
- a. purifying viral particles from harvested cell culture;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein activating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising a non-ionic surfactant and an ionic surfactant, and wherein the non-ionic surfactant and the ionic surfactant are present in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated in a sub-virion form, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising a non-ionic surfactant and an ionic surfactant, and wherein the non-ionic surfactant and the ionic surfactant are present in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated comprising purified viral proteins, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions to produce purified viral proteins;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising a non-ionic surfactant and a salt, and wherein the non-ionic surfactant and the salt are in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated comprising purified viral proteins, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions to produce purified influenza viral proteins;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising an ionic surfactant and a salt, and wherein the ionic surfactant and the salt are in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated comprising purified viral proteins, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. treating the purified viral particles with alkylating agent to inactivate the viral particles;
- c. treating the inactivated viral particle with an ionic surfactant to split the inactivated viral particles to produce subvirions;
- and
- d. purifying the sub-virions to produce purified influenza viral proteins;
- wherein inactivating and splitting the viral particles of step b and/or c further comprises treating the viral particles with a reagent comprising a non-ionic surfactant and an ionic surfactant, and wherein the non-ionic surfactant and the ionic surfactant are in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated in a sub-virion form, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising CTAB, NaCl, and polysorbate 80, in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated in a sub-virion form, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising 1.5-2.5 g/L CTAB, 0-150 mM NaCl, and 0-2.2 g/L polysorbate 80, in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated in a sub-virion form, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising 1.5-2.5 g/L of an ionic surfactant, 0-150 mM of a salt, and 0-2.2 g/L of a non-ionic surfactant, in an amount effective to reduce particle size of the viral particles.
A method of producing an influenza viral vaccine formulated in a sub-virion form, the method comprising the steps:
- a. purifying viral particles from a harvested cell culture of MDCK cells;
- b. inactivating and splitting the viral particles to produce sub-virions;
- and
- c. purifying the sub-virions;
- wherein inactivating and splitting the viral particles of step b comprises treating the viral particles with a reagent comprising CTAB, NaCl, and polysorbate 80, in an amount selected from the group consisting of conditions 1 through 27 of Table 1.
Dependencies are inferred from the claim text.