Methods for reducing contamination in a biological substance
Inventors
Chan, Phillip P. • Capponi, Vincent J. • Golobish, Thomas D. • Ali, Humayra Begum
Assignees
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Publication Number
US-11602585-B2
Publication Date
2023-03-14
Expiration Date
Abstract
Provided herein are materials and methods of reducing contamination in a biological substance or treating contamination in a subject by one or more toxins comprising contacting the biological substance with an effective amount of a sorbent capable of sorbing the toxin, wherein the sorbent comprises a plurality of pores ranging from 50 Å to 40,000 Å with a pore volume of 0.5 cc/g to 5.0 cc/g and a size of 0.05 mm to 2 cm and sorbing the toxin. Also provided are kits to reduce contamination by one or more toxins in a biological substance comprising a sorbent capable of sorbing a toxin, wherein the sorbent comprises a plurality of pores ranging from 50 Å to 40,000 Å with a pore volume of 0.5 cc/g to 5.0 cc/g and a size of 0.05 mm to 2 cm and a vessel to store said sorbent when not in use together with packaging for same.
Core Innovation
The invention relates to a method of reducing contamination by contacting a biological substance with an effective amount of a sorbent capable of sorbing one or more toxins, and then sorbing the toxin. The method is applied to toxins in a biological substance and includes contacting the biological substance in vivo, in vitro, ex vivo, and extracorporeal contexts as described. The toxins include endogenous toxins having a molecular weight greater than 50,000 Daltons, and exotoxins produced by a micro-organism comprising one or more bacteria, viruses, fungi or parasites.
The sorbent comprises a plurality of pores and is described as a coated polymer. The plurality of pores ranges from 50 Å to 40,000 Å, with a pore volume of 0.5 cc/g to 5.0 cc/g, and a size of 0.05 mm to 2 cm. The toxins comprise proteins, peptides, carbohydrates, lipids, nucleic acids, or combinations thereof, and the sorbent is defined to sorb the toxin by applying these structural pore characteristics.
The method further defines quantitative pore-volume ratio constraints for the sorbent to characterize the pore structure. It specifies that the ratio of pore volume between 50 Å to 40,000 Å (pore diameter) to pore volume between 100 Å to 1,000 Å (pore diameter) is smaller than 3:1, or alternative ratios are smaller than 2:1 or smaller than 3:1 for other defined pore-diameter ranges. The documented description includes characterization of pore structure and removal over time for multiple toxins including C. difficile Toxin A and C. difficile Toxin B.
Claims Coverage
The partial content provides one independent claim (clm-00001), which covers a method of reducing toxin contamination using a specifically defined coated-polymer sorbent with defined pore size, pore volume, and pore-volume ratio constraints, for endogenous toxins and exotoxins with specified molecular-weight and composition ranges.
Contacting a biological substance with an effective sorbent and sorbing toxins
A method comprising contacting a biological substance with an effective amount of a sorbent capable of sorbing the toxin, and sorbing the toxin, where the toxins include endogenous toxins having a molecular weight greater than 50,000 Daltons and exotoxins produced by microorganisms, and where the toxins comprise proteins, peptides, carbohydrates, lipids, nucleic acids, or combinations thereof.
Coated polymer sorbent with specified pore size and pore volume
The sorbent comprises a plurality of pores ranging from 50 Å to 40,000 Å with a pore volume of 0.5 cc/g to 5.0 cc/g, a size of 0.05 mm to 2 cm, and comprises a coated polymer comprising at least one crosslinking agent.
Pore-volume ratio constraints for selecting pore structure ranges
The sorbent has pore-volume ratio constraints selected from (i) the ratio of pore volume between 50 Å to 40,000 Å to pore volume between 100 Å to 1,000 Å is smaller than 3:1; (ii) the ratio of pore volume between 50 Å to 40,000 Å to pore volume between 1,000 Å to 10,000 Å is smaller than 2:1; or (iii) the ratio of pore volume between 50 Å to 40,000 Å to pore volume between 10,000 Å to 40,000 Å is smaller than 3:1.
Claim coverage centers on the combination of (1) contacting a biological substance with an effective coated-polymer sorbent, (2) using sorbent pore characteristics (pore size range, pore volume, sorbent size, and a coated polymer including at least one crosslinking agent), and (3) enforcing pore-volume ratio constraints across defined pore-diameter ranges while targeting endogenous toxins (>50,000 Daltons) and exotoxins with specified molecular composition.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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