Methods of producing and characterizing virus vaccine and virus vaccine composition
AssigneesGuangzhou Realbenefitspot Pharmaceutical Co., Ltd., Guangzhou Yinheyangguang Biologics 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.
Claims17
A method of purifying an enveloped virus from a biological sample, comprising subjecting the biological sample to an ion exchange (“IE”) chromatography followed by a hydroxyapatite (“HA”) chromatography, wherein the enveloped virus has one or more outer membrane proteins on the surface of the enveloped virus,
- wherein:
- a) the IE chromatography is an anion exchange (“AE”) chromatography when the outer membrane proteins overall have negative charges;
- or b) the IE chromatography is a cation exchange (“CE”) chromatography when the outer membrane proteins overall have positive charges,
- wherein the IE chromatography comprises:
- a) an IE loading step, comprising loading the biological sample to the ion exchange column;
- and
- b) an IE elution step, comprising eluting the IE column with an IE elution buffer,
- wherein the HA chromatography comprises:
- a) an HA loading step, comprising loading a post-IE chromatography sample to the HA column;
- and
- b) an HA elution step, comprising eluting the HA column with an HA elution buffer, wherein the HA elution buffer is a calcium buffer or a phosphate buffer, and wherein the HA chromatography steps are carried out after the IE chromatography steps.
Dependencies are inferred from the claim text.