Method for influenza virus protection

Abstract

A process for the purification of influenza virus or derivative thereof comprising the steps of: providing a source having influenza virus or derivative thereof; optionally subjecting the source to a prepurification step; followed by at least one chromatographic step on chromatographic materials selected from the group consisting of porous particles having mean pore sizes of at least 20 nm, perfusion particles, gel-in-a-shell particles, tentacle like particles, membrane adsorbers, and monoliths; collecting eluting influenza virus or derivatives thereof containing fractions with the proviso that sulfuric ester of cellulose or cross-linked polysaccharides are excluded.

1 . A process for the purification of influenza virus or derivative thereof comprising the steps of:
 providing a source having influenza virus or derivative thereof;   optionally subjecting the source to a prepurification step;   followed by at least one chromatographic step on chromatographic materials selected from the group consisting of porous particles having mean pore sizes of at least 20 nm, perfusion particles, gel-in-a-shell particles, tentacle like particles, membrane adsorbers, and monoliths;   collecting eluting influenza virus or derivatives thereof containing fractions   with the proviso that sulfuric ester of cellulose or of cross-linked polysaccharides are excluded.   
   
   
       2 . The process of  claim 1  wherein at least one further chromatographic step is performed on materials selected from the group consisting of porous particles having mean pore sizes of at least 20 nm, perfusion particles, gel-in-a-shell particles, tentacle like particles, membrane adsorbers, and monoliths. 
   
   
       3 . The process of  claim 1  wherein the porous particles have mean pore sizes of from 20 nm to about 500 nm or even more measured by mercury porosimetry. 
   
   
       4 . The process of  claim 1  wherein the prepurification step is centrifugation, filtration, ultra filtration, selective precipitation, expanded bed chromatography, batch chromatography including magnetic beads or combinations thereof. 
   
   
       5 . The process of  claim 1  wherein after the at least one chromatographic step on porous particles, membrane adsorbers, and monoliths an ultra filtration and/or a sterile filtration is performed. 
   
   
       6 . The process of  claim 1  wherein in the at least one chromatographic step ion exchange, affinity, groups providing for hydrophobic or hydrophilic interaction of the chromatographic material and a sample, and/or size exclusion materials are employed. 
   
   
       7 . The process of  claim 1  wherein the influenza virus or derivative thereof are selected from the group consisting of influenza virus wild type, influenza virus containing modifications including substitution mutations insertions and/or deletions, and immunogenic influenza-virus-like particles. 
   
   
       8 . The process of  claim 1  wherein the influenza virus contains at least one modification and/or deletion of the NS1 gene. 
   
   
       9 . A process for the purification or manufacturing of influenza virus or derivative thereof comprising the steps of:
 Infecting cells with influenza virus;   propagating the influenza virus in the cells;   harvesting of the influenza viruses; and   subjecting the harvested influenza virus or derivative thereof to a purification according to  claim 1 .   
   
   
       10 . The process of  claim 9  for the purification of influenza virus or derivative thereof comprising the steps of:
 infecting cells with influenza virus;   propagating the influenza virus in the cells;   harvesting of the influenza virus;   concentrating the harvested influenza virus with a tangential flow filtration on flat sheet or hollow fiber device with 300 kDa cut off;   subjecting the concentrated influenza virus to CIM QA monolithic column;   subjecting the influenza virus fractions eluted from CIM QA monolithic column to Sepharose 6 FF column;   collecting influenza virus fractions from Sepharose 6 FF column   sterile filtration of influenza virus fractions   
   
   
       11 . A fraction of influenza virus or derivative thereof obtainable according to a process of  claim 1 . 
   
   
       12 . A vaccine obtainable according to a process of  claim 1  optionally comprising adjuvants, and/or pharmaceutically acceptable carriers. 
   
   
       13 . A fraction comprising an influenza virus vector obtainable according to  claim 7 .