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Last Updated: September 19, 2021

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Claims for Patent: 9,469,847


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Summary for Patent: 9,469,847
Title:Ultrapure hypoallergenic solutions of sacrosidase
Abstract: One aspect provides an ultrapure, hypoallergenic sacrosidase. Another aspect provides a solution of sacrosidase in about 1:1 glycerol/water having an enzymatic activity of at least about 7500 IU/mL and a residual papain concentration that does not include an allergic reaction in a human patient when given a dose of about 2.0 mL/day.
Inventor(s): Reardan; Dayton T. (Shorewood, MN), Seekamp; Christopher (Brookfield, WI)
Assignee: QOL Medical LLC (Vero Beach, FL)
Application Number:14/828,006
Patent Claims: 1. A solution of sacrosidase derived from Saccharomyces in about 1:1 glycerol/water having an enzymatic activity of at least about 7500 IU/mL and residual papain in a concentration of less than about 10 ng/mL papain, wherein a daily dose of the solution of about 2-10 mL per day does not induce an allergic reaction in a human patient afflicted with congenital sucrase-isomaltase deficiency, wherein the primary structure of the sacrosidase is a 513 amino acid polypeptide that is glycosylated.

2. The solution of sacrosidase of claim 1 that contains less than about 3.0 ng/mL papain.

3. The solution of sacrosidase of claim 1 that contains no detectable papain by an enzyme-linked immunosorbant assay having a lower limit of quantification of 3 ng/mL.

4. The solution of sacrosidase of claim 1 that contains no detectable papain by SDS-PAGE of up to about 15 .mu.g of said solution.

5. The solution of sacrosidase of claim 1 having an enzymatic activity of about 7500-10,000 IU/ml.

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