Virus purification
AssigneeValneva SE
InventorsJana Barbero Calzado, Mario Nebenführ, Robert Schlegl, Michael Weber, Jürgen Heindl-Wruss
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Abstract
Described herein are improved purification methods for virus vaccines and compositions. Also described are Zika, Chikungunya, dengue and yellow fever vaccines and methods of producing and administering said vaccines to subjects in need thereof.
Claims12
A method for removal of protamine from purified infectious virus particles, comprising a step of sucrose gradient centrifugation, wherein the sucrose gradient comprises a virus comprising fraction in a 10%+/−1% (w/w) sucrose solution and three further layers of sucrose solutions with different densities, wherein the three further layers of sucrose solutions comprise a first sucrose solution with 15%+/−1% (w/w) sucrose, a second sucrose solution with 35%+/−1% (w/w) sucrose, and a third sucrose solution with 50%+/−1% (w/w) sucrose.
A method for purification of infectious virus particles, comprising the steps of
- a) providing a crude harvest (a) comprising virus particles and impurities, wherein the impurities are generated from growing said virus particles on a cell substrate;
- b) reducing impurities from said crude harvest (a) by precipitation with an agent comprising protamine to obtain a virus preparation (b);
- c) further purifying said virus preparation (b) by sucrose density gradient centrifugation to obtain a virus preparation (c), wherein the sucrose gradient is provided such that the protamine can be completely or almost completely separated from the virus fraction;
- and wherein the protamine concentration is reduced by this step to the extent that the protamine concentration in the final drug substance is below 1 μg/ml, and wherein said sucrose density gradient comprises a virus comprising fraction in a 10%+/−1% (w/w) sucrose solution and three layers of sucrose with different densities, wherein the three further layers of sucrose solutions comprise a first sucrose solution with 15%+/−1% (w/w) sucrose, a second sucrose solution with 35%+/−1% (w/w) sucrose, and a third sucrose solution with 50%+/−1% (w/w) sucrose.
Dependencies are inferred from the claim text.