US 2026/0249207 A1 · Spray Dried Blood Products

Abstract

The present invention relates to a spray dried blood component composition having one or more of the following characteristics: when reconstituted, largely amorphous and has no cholesterol crystals; when reconstituted, the mean size of large particulates is reduced; has low residual moisture; reconstitutes rapidly in under four minutes; highly stable when stored under refrigeration, at room temperature or at elevated temperatures and allows for storage for longer periods of time; when reconstituted, exhibits recovery of the most fragile of proteins, including von Willebrand's factor; when reconstituted with Sterile Water for Injection (SWFI), reconstituted blood component is at a pH that is near normal pH, and does so without treatment or storage in CO2 or other pH adjustment.

Claims36

Dependent claims

1) A method of spray drying a liquid plasma derived acellular blood component using a spray drying system, wherein the liquid plasma derived acellular blood component is substantially devoid of cells, the method comprising the step of:

a) drying the liquid plasma derived acellular blood component using the spray drying system to thereby obtain a spray dried plasma derived acellular blood product.

21) A spray dried plasma derived acellular blood product made from a plasma derived acellular blood component, said spray dried plasma derived acellular product comprises:

a) dried particles having a size ranging between about 1 and about 7 microns;
b) when reconstituted, a reduced mean size of particulates when measuring with a Coulter Multisizer 4 by the electrical sensing zone method for particulates having a size between about 2 μm and 60 μm, as compared to particulates in the donor blood component;
c) when reconstituted has a reduced number of cholesterol crystals, when viewed at 100× magnification, as compared to freeze dried blood component;
d) a residual moisture in a range between about 0.5% and about 2.5%;
e) stability when stored for a period of time between about 1 day and about 48 months at a temperature ranging between about −80° C. and about 45° C., as compared to reconstituted spray dried blood product before storage;
f) when reconstituted, stability for transfusion, after storage for up to about 26 hours;
g) when reconstituted with Sterile Water For Injection (SWFI), a pH of between about 6.5 to about 7.8,
h) when reconstituted, an amount of von Willebrand factor (vWF) that induces clot formation;
i) when reconstituted, a C5a level, C3a level or both as compared to that of apheresed blood product;
and
j) any combination thereof.

8 more elements

32) A rehydrated previously spray dried plasma derived acellular blood product, wherein a previously spray dried plasma derived acellular blood component is dried from one or more plasma derived acellular blood components from one or more donors, said rehydrated previously spray dried plasma derived acellular blood product comprises:

a) a reduced mean size of particulates when measuring with a Coulter Multisizer 4 by the electrical sensing zone method for particulates having a size between about 2 μm and 60 μm, as compared to particulates in the donor blood component;
b) a reduced number of cholesterol crystals, when viewed at 100× magnification, as compared to freeze dried blood component;
c) stability for transfusion, after storage for up to about 26 hours;
d) a pH of between about 6.5 to about 7.8, when reconstituted with SWFI;
e) an amount of von Willebrand factor (vWF) that induces clot formation;
f) a C5a level, C3a level or both as compared to that of apheresed donor blood component;
and
g) any combination thereof.

5 more elements

Dependencies are inferred from the claim text.

Spray Dried Blood Products

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Spray Dried Blood Products

Life of this patent

Abstract

Claims36