Desiccated biologics and methods of preparing the same
Inventors
Ho, David H. • Bruttig, Stephen P.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-9642353-B2
Publication Date
2017-05-09
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 desiccated biologics compositions and preservation methods that maintain biologics in a dry or semi-dry state across broad moisture contents by using at least one membrane penetrable sugar and at least one membrane impenetrable sugar. The membrane penetrable sugar is exemplified by trehalose, and the membrane impenetrable sugar is exemplified by dextran, such as Dextran-70.
The document describes preserving red blood cells and platelets by contacting the red blood cell or platelet with the membrane penetrable sugar and the membrane impenetrable sugar, and then drying to a final moisture content from 5% to 90%. It further provides embodiments for other biologics, including nucleated cells and macromolecules including proteins, nucleic acids, viruses, and lipids.
The preservation approach includes embodiments with optional fixative agent(s) such as glutaraldehyde and paraldehyde, and drying/storage/reconstitution concepts that include vacuum desiccation and rehydration. Representative results described in the document indicate preservation of red blood cell morphology and platelet sizing/fragmentation characteristics, and retention of viability and/or surface marker profiles upon reconstitution.
Claims Coverage
The independent claim coverage includes 1 independent claim directed to preserving a red blood cell or platelet. The main inventive concept comprises two sugar components and drying at a specified temperature/time to achieve a final moisture content in a broad range, with dependent claims refining sugar identity, moisture targets, and narrowing drying to vacuum desiccation.
Membrane penetrable and membrane impenetrable sugar contacting for red blood cells or platelets
Contacting the red blood cell or platelet with at least one membrane penetrable sugar and at least one membrane impenetrable sugar.
Drying temperature/time and final moisture content for preservation
Drying the red blood cell or platelet at a temperature from about 0°C to about 40°C for about 1 hours to about 4 hours to a final moisture content from 5% to 90%.
Trehalose and dextran sugar selection
Using trehalose as the membrane penetrable sugar and dextran as the membrane impenetrable sugar.
Moisture content refinement for preservation
Setting the final moisture content to within about 15% to about 40%.
Vacuum desiccation drying
Performing the drying step by vacuum desiccation.
Across the claim set, preservation is achieved by contacting red blood cells or platelets with both a membrane penetrable sugar and a membrane impenetrable sugar, then drying within a defined temperature and time window to reach a final moisture content between 5% and 90%, with dependent claim refinements for specific moisture ranges and vacuum desiccation.
Stated Advantages
Maintains red blood cells or platelets in a dry or semi-dry state across broad moisture contents (5% to 90%).
Preserves red blood cell morphology/size upon reconstitution.
Preserves platelet sizing/fragmentation characteristics upon reconstitution.
Supports viability and/or surface marker retention after rehydration.
Documented Applications
No documented applications found
Interested in licensing this patent?