Preservation solutions for biologics and methods related thereto
Inventors
Ho, David • Bruttig, Stephen P.
Assignees
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Publication Number
US-9943075-B2
Publication Date
2018-04-17
Expiration Date
Abstract
The present invention provides compositions (i.e., preservation solutions) for preserving biologies comprising at least one membrane penetrable sugar, at least one membrane impenetrable sugar, at least one anti-microbial agent, at least one anti-oxidant, adenosine, albumin, a salt, a buffer, and a chelating agent, and to methods of using such preservation solutions to preserve biologies.
Core Innovation
The invention relates to a non-cryogenic preservation solution for a biologic. The solution includes about 0.1% w/v to about 12% w/v trehalose and about 2% w/v glucose, and about 0.01% w/v to about 25% w/v Dextran-70, together with mannitol, and the preservation solution does not contain a permeabilizer.
The non-cryogenic preservation solution functions without lyophilization, freeze-drying, vacuum drying and/or oven drying methods. The formulation is directed to preserving biologics without cryogenic preservation approaches and without those drying methods.
In representative formulations, the solution combines membrane penetrable and impenetrable sugars, including trehalose with glucose and Dextran-70, and further includes anti-microbial agents and anti-oxidants, as well as adenosine, salts/buffers, and chelating agents, with optional albumin. The disclosed example compositions include trehalose, glucose, Dextran-70, sulfanilamide, mannitol/vitamin E, NaCl, K2HPO4, EDTA, and adenosine in non-cryogenic preservation solutions for different biologics.
The disclosed biologics include red blood cells, platelets, stem/endothelial cells, B-cells, and other cells such as CHO cells and HEK cells, as well as cryoprecipitate and enzymes including Factor VIII activity. The document states that non-cryogenic preservation solutions are provided that support handling/shipping without lyophilization and improve ambient-temperature shelf life and recovery/viability.
Claims Coverage
The document contains one independent claim defining a non-cryogenic preservation solution with specific solute ranges and an explicit absence of a permeabilizer, and that functions without lyophilization, freeze-drying, vacuum drying, and oven drying. The remaining claims are dependent refinements that constrain composition details and optional components, including antimicrobial agent options and additional quantitative limitations.
Non-cryogenic preservation solution without permeabilizer and without drying
A non-cryogenic preservation solution for a biologic comprising about 0.1% w/v to about 12% w/v trehalose and about 2% w/v glucose; about 0.01% w/v to about 25% w/v Dextran-70; and mannitol, wherein the preservation solution does not contain a permeabilizer; and wherein the non-cryogenic preservation solution functions without lyophilization, freeze-drying, vacuum drying, and/or oven drying methods.
Trehalose concentration constrained to discrete levels
A preservation solution as recited wherein trehalose is present at approximately 2% w/v, 3% w/v, 4% w/v, or 5% w/v.
Dextran-70 concentration fixed
The preservation solution wherein Dextran-70 is present at about 3% w/v.
Antimicrobial agent specified as sulfanilamide
The preservation solution wherein the anti-microbial agent is sulfanilamide.
Antimicrobial agent concentration constrained to enumerated ranges
A preservation solution wherein the anti-microbial agent is present at one of the listed concentration ranges: 0.001%, 0.1%, 0.005%, 0.075%, 0.01%, 0.05%, 0.015%, or 0.025%.
Mannitol constrained to discrete molar amount options
A preservation solution wherein mannitol is present at 0.11 mmol, 0.44 mmol, 0.77 mmol, or 1.1 mmol.
Overall claim coverage centers on a non-cryogenic preservation solution formulated with trehalose, glucose, Dextran-70, and mannitol, explicitly excluding a permeabilizer and requiring function without lyophilization, freeze-drying, vacuum drying, and oven drying. Dependent claim coverage further restricts trehalose and Dextran-70 levels and adds optional antimicrobial content with specified identities and enumerated concentration ranges, plus discrete mannitol molar amount options.
Stated Advantages
Supports shipping and handling without lyophilization and without lyophilization, freeze-drying, vacuum drying, and/or oven drying methods.
Improved ambient-temperature shelf life.
Improved recovery and viability.
Documented Applications
Non-cryogenic preservation of red blood cells.
Non-cryogenic preservation of platelets.
Non-cryogenic preservation of stem/endothelial cells.
Non-cryogenic preservation of B-cells.
Non-cryogenic preservation of cryoprecipitate, including Factor VIII activity.
Non-cryogenic preservation of enzymes.
Non-cryogenic preservation of cells including CHO cells and HEK cells.
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