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AssigneeBoehringer Ingelheim Animal Health USA Inc.
InventorsLeigh WILMES, Matthew COONS, Amanda BROWN, Michael Johannes GASSEL, Francois-Xavier ORVEILLON, Katharina Hedwig TOEPFER, Elida BAUTISTA, Kathy SCHLESINGER
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The present invention in particular relates to a method of producing an immunogenic composition exhibiting reduced virucidal activity, as well as to the immunogenic composition and uses thereof, wherein the method in particular comprises the steps of: (a) providing a mixture with a first liquid and a recombinant protein, (b) concentrating the recombinant protein in the mixture by removing a portion of the first liquid from the mixture, and (c) processing the solution resulting from step (b) by continuous diafiltration.
A method of producing an immunogenic composition comprising a recombinant protein, wherein the method comprises the steps of:
The method according to any one of items 1 to 13, wherein the virucidal activity of the immunogenic composition resulting from said method is reduced by at least 20% as compared to an immunogenic composition mixture that has not undergone the concentrating of step (b) and the continuous diafiltration of step (c) of said method, and/or wherein the immunogenic composition produced by said method causes a loss of less than 1 log TCID50 per mL of a live virus, preferably of less than 0.7 log TCID50 per mL of a live virus, when the live virus is mixed with the immunogenic composition for four or more hours, in particular at room temperature.
Dependencies are inferred from the claim text.