Reduction of leachable beta-glucan levels from cellulose-containing filter materials
Inventors
Gupta, Akshat • Kinzlmaier, Dana • Pizzelli, Kara • Goodrich, Elizabeth
Assignees
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Publication Number
US-12053729-B2
Publication Date
2024-08-06
Expiration Date
Abstract
Treatment methods for reduction of (1→3)-β-D-glucan leachables from cellulose-containing filter materials are described.
Core Innovation
A solution containing a carbonate salt, an organic carbonate, or carbonic acid is used to treat a cellulose-containing filter material in order to reduce the amount of leachable beta-glucans. The treated filter material targets leachable (1→2)-β-D-glucan present as leachables that otherwise transfer from the cellulose-containing filter material.
The document describes carbonate treatment formats including contacting, soaking, flushing/washing, and recirculating with the carbonate salt, organic carbonate, or carbonic acid solution. Reported solution parameters include a pH of about 7.5 to about 12 and a carbonate concentration of about 0.005 mM to about 2 M, with example preferred ranges cited as about 0.01 M to about 0.5 M.
Cellulose-containing filter materials described include depth filters and cellulose fiber materials, including wood pulp derived fibers, cotton derived fibers, and regenerated cellulose, with optional combinations such as cellulose/silica blends and cellulose derivatives such as cellulose acetate and cellulose triacetate. Comparative performance is described for sodium versus potassium carbonate, with reduction of leached beta-glucans observed using carbonate flushing, recirculation, and soaking approaches.
Claims Coverage
The patent includes one independent claim directed to a carbonate/carbonic-acid solution treatment for reducing leachable beta-glucans in a cellulose-containing filter material, with dependent claims adding quantitative and compositional limitations. The main inventive features include the treating solution types and additional constraints on pH, carbonate concentration, treatment time, and the cellulose-containing filter composition, plus a use claim for preparing biopharmaceuticals or plasma derivatives with reduced leached beta-glucan.
Carbonate or carbonic-acid treatment of cellulose-containing filter material
A method for reducing the amount of leachable beta-glucans in a cellulose-containing filter material by treating the filter material with a solution comprising a carbonate salt, an organic carbonate, or carbonic acid.
Specified carbonate concentration for the treatment solution
The method treats the filter material with a solution that contains a carbonate salt or an organic carbonate with a carbonate concentration between about 0.01 M and about 0.5 M.
Specified pH range for the treatment solution
The method treats the filter material with a solution having a pH in the range from about 7.5 to about 12.
Immersion time for treating the filter material
The method immerses the filter material in a solution for about 1 to 240 minutes.
Cellulose fiber composition and optional additives in the filter material
The filter material comprises fibers of cellulose, optionally in combination with particular inorganic filter aids, organic resins, cellulose/silica blends, or cellulose derivatives such as cellulose acetate or cellulose triacetate, in any combination.
Preparing a biopharmaceutical or plasma derivative with reduced leached beta-glucan
A method prepares a biopharmaceutical or plasma derivative with a reduced amount of leached beta-glucan by treating the biopharmaceutical or plasma derivative with cellulose-containing filter material treated as in the carbonate/carbonic-acid method, compared to contacting with untreated cellulose-containing filter material.
Overall claim coverage centers on reducing leachable beta-glucans by treating a cellulose-containing filter material with a carbonate salt, an organic carbonate, or carbonic acid solution, with dependent limitations covering carbonate concentration, pH range, immersion time, and cellulose fiber composition/additives. Additional coverage extends the treatment to preparing biopharmaceuticals or plasma derivatives with reduced leached beta-glucan versus an untreated comparator.
Stated Advantages
Reduces the amount of leachable beta-glucans in a cellulose-containing filter material.
Reduces the amount of leached beta-glucan in a biopharmaceutical or plasma derivative when compared to contacting with untreated cellulose-containing filter material.
Compared to NaOH, carbonate flushing is described as reducing leached beta-glucans, while NaOH is described as increasing leachables.
Documented Applications
Treating cellulose-containing filter materials used in preparing biopharmaceuticals and plasma derivatives to reduce leached beta-glucan.
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