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Last Updated: May 6, 2024

Claims for Patent: 9,255,261

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Summary for Patent: 9,255,261

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:	14/175,263
Patent Claims:	1. Hypoallergenic sacrosidase prepared by a process comprising: (a) digesting an aqueous suspension of saccharomyces cerevisiae at a pH of about 7.0 with an amount of papain effective to cleave non-sacrosidase proteins in said suspension while not cleaving sacrosidase in said suspension; (b) acidifying and filtering the digested suspension to remove cell debris yield an acidified filtrate; (c) treating the acidified filtrate with one or more decolorizing agents to yield a decolorized suspension; (d) filtering and concentrating the decolorized suspension to yield a concentrated sacrosidase solution; (e) diafiltering the concentrated sacrosidase solution to yield a solution of-hypoallergenic sacrosidase, wherein the primary structure of the sacrosidase is a 513 amino acid polypeptide that is glycosylated, and wherein the solution has a sacrosidase activity of at least about 22,000 IU/mL in water at a pH of about 4.6 .+-.0.1 and has a residual papain level of less than about 50 ppb (50 nanograms/mL) papain. 2. The sacrosidase of claim 1 wherein step (d) comprises sparkler filtration followed by ultrafiltration. 3. The sacrosidase of claim 1 wherein the decolorizing agent comprises activated charcoal. 4. The sacrosidase of claim 1 wherein the diafiltration is carried out against four or more volumes of citrate buffer. 5. The sacrosidase of claim 1 further comprising adding about 45-54 wt-% glycerol to the aqueous solution of sacrosidase.

Details for Patent 9,255,261

Glossary

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Qol Medical, Llc	SUCRAID	sacrosidase	Solution For Oral	020772	04/09/1998	⤷ Try a Trial	2040-03-31
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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