Methods of producing and characterizing virus vaccine and virus vaccine composition
AssigneeGuangzhou Realbenefitspot Pharmaceutical Co., Ltd.
InventorsDianlian Liu, Wen Ai, Mingfeng Shen
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Abstract
This application pertains to methods of isolating virus particles and producing virus vaccine composition comprising subject a biological sample to an anion exchange chromatography and a hydroxyapatite chromatography. The application also pertains to rabies virus vaccine compositions and methods of assessing suitability of a virus vaccine composition or releasing a commercial batch of virus vaccine composition for clinical use.
Claims23
1-52. (canceled)
A virus composition comprising rabies virus particles,
- wherein at least about 80% of the total protein in the composition is viral protein,
- wherein the viral protein comprises:
- at least about 35-48% protein G.
A method of assessing suitability of a virus vaccine composition comprising rabies virus particles for clinical use, comprising:
- a) determining the percentage of viral proteins out of the total protein in the composition and
- b) determining the relative percentage of each of G, N, P, M in the viral proteins, wherein the composition is suitable for clinical use if
- i) at least about 80% of the total protein in the composition is viral protein, and
- ii) the viral protein comprises:
- about 35-48% protein G.
(canceled)
A method of releasing a commercial batch of a virus vaccine composition comprising rabies virus particles for clinical use, comprising:
- a) determining the percentage of viral proteins out of the total protein in the composition;
- b) determining the relative percentage of each of G, N, P, M in the viral proteins, and
- c) releasing the commercial batch for clinical use if
- i) at least about 80% of the total protein in the composition is viral protein, and
- ii) the viral protein comprises about 35-48% protein G.
74-76. (canceled)
Dependencies are inferred from the claim text.