Back to results
US 11,911,457 B2Granted
Process for enterovirus purification and inactivation and vaccine compositions obtained thereof
AssigneeBharat Biotech International Limited
InventorsKrishna Murthy Ella, Vijaya Kumar Daram
Life of this patent
Estimating the term…
Abstract
The present invention pertains to the field of industrial scale inactivation of various enteroviruses and large and industrial scale production of enterovirus vaccine compositions and combinations of various enteroviruses so obtained.
Claims15
A method for producing Enteroviral particles useful for preparation of vaccine compositions, wherein the method comprises the steps of:
- a. producing Enteroviral particles in Vero cells;
- b. purification of the Enteroviral particles by two step chromatography;
- c. stabilization of purified Enteroviral particles;
- and
- d. chemical inactivation of the Enteroviral particles in presence of formalin (0.025%) at 37° C. for 13 days in presence of an inactivation buffer to obtain Enteroviral particles;
- wherein the said method comprises addition of one or more stabilizers before the inactivation step, wherein recovery of the Enteroviral particles is in the range of 80% to 99%, and wherein the two step chromatography is carried out by first running size exclusion chromatography followed by ion exchange chromatography.
3 more elements
A method for preparing a dose reduced inactivated Polio vaccine containing Sabin polioviruses, said method comprising the steps of:
- a. producing polioviruses in Vero cells;
- b. purification of the polioviruses by two step chromatography;
- c. stabilization of purified polioviruses by addition of M-199 medium containing glycine and tween 80;
- d. inactivation of the polio viruses by using formaldehyde 0.025% at 37° C. for 13 days in presence of phosphate buffer with saline at a concentration between 2 mM to 10 mM or sodium acetate to reduce aggregation of the poliovirus particles thereby reducing the poliovirus particles losses post inactivation by greater than 90% as compared to other buffers;
- and
- e. formulating the said polio vaccine, wherein the two step chromatography is carried out by first running size exclusion chromatography followed by ion exchange chromatography.
3 more elements
Dependencies are inferred from the claim text.