Desiccated biologics and methods of preparing the same
Inventors
Ho, David H. • Bruttig, Stephen P.
Assignees
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Publication Number
US-8628960-B2
Publication Date
2014-01-14
Expiration Date
Abstract
The present invention provides compositions comprising desiccated biologics comprising a cell, protein, virus, nucleic acid, carbohydrate, or lipid, or any combination thereof, along with at least one membrane penetrable sugar, and at least one membrane impenetrable sugar, wherein the moisture content is from 5% to 95%, and to methods of preparing the same, and to methods of treating animals using the same.
Core Innovation
The invention relates to preserving desiccated biologic compositions by stabilizing cells and biomolecules for drying and subsequent rehydration. A desiccation formulation includes a membrane penetrable sugar in combination with a membrane impenetrable neutral dextran having a molecular weight greater than or equal to 50,000 daltons.
The compositions are provided as dried cells at a final moisture content of from about 5% to about 90%, and the cells are dried by vacuum desiccation. The disclosure includes embodiments in the range of about 5% to about 15% and other moisture-content ranges such as about 15% to about 40%, with viability upon rehydration reported as about 30% or greater.
The preservation approach optionally includes contacting the cells with a fixative agent, and the document further describes preservation methods that include vacuum drying and rehydration. The disclosure covers embodiments for multiple biologic types including platelets, red blood cells, nucleated cells, white blood cells, stem cells, gametes, hepatocytes, proteins, and viruses.
Claims Coverage
The independent claim set includes two independent claims, which share the core inventive concept of stabilizing a cell for vacuum desiccation using a membrane penetrable sugar together with a neutral dextran (MW ≥ 50,000 daltons), optionally with a fixative agent, and drying to a final moisture content between about 5% and about 90%.
Membrane penetrable sugar with neutral dextran stabilization and vacuum desiccation viability
Contacting the cell with at least one membrane penetrable sugar; contacting the cell with a neutral dextran with a molecular weight greater than or equal to 50,000 daltons; optionally contacting the cell with a fixative agent; and drying the cell by vacuum desiccation to a final moisture content of from about 5% to about 90%, wherein the % viability of the dried cell upon rehydration is about 30% or greater.
Suspension introduction of membrane penetrable sugar with neutral dextran and vacuum desiccation moisture range
Introducing into the cell at least one membrane penetrable sugar by a method consisting of suspending the cell in a solution comprising the at least one membrane penetrable sugar; contacting the cell with a neutral dextran with a molecular weight greater than or equal to 50,000 daltons; optionally contacting the cell with a fixative agent; and drying the cell by vacuum desiccation to a final moisture content of from about 5% to about 90%.
Across both independent claims, the claims are directed to preserving cells from a cell line for vacuum desiccation using a membrane penetrable sugar and a neutral dextran (MW ≥ 50,000 daltons), with an optional fixative agent, and drying to a final moisture content of about 5% to about 90%; one independent claim further requires about 30% or greater viability upon rehydration.
Stated Advantages
About 30% or greater % viability of the dried cell upon rehydration.
Documented Applications
Preserving biological entities including platelets, red blood cells, nucleated cells, white blood cells, stem cells, gametes, hepatocytes, proteins, and viruses as desiccated compositions stabilized for rehydration.
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