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.
Claims21
A method of purifying rabies virus from a biological sample, comprising subjecting the biological sample to an anion exchange (“AE”) chromatography followed by a hydroxyapatite (“HA”) chromatography,
- wherein the AE chromatography comprises:
- a) an AE loading step, comprising loading the biological sample to an AE column, and b) an AE elution step, comprising eluting the AE column with an AE elution buffer having a pH of 7.0 to 9.5;
- and
- wherein the HA chromatography comprises:
- a) an HA loading step, comprising loading a post-AE chromatography sample to an HA column, and b) an HA elution step, comprising eluting the HA column with an HA elution buffer, and wherein the HA elution buffer is a phosphate buffer having a pH of 7.0 to 9.5.
Dependencies are inferred from the claim text.