Method of producing glycine-stabilized, lyophilized plasma

Details Method of producing glycine-stabilized, lyophilized plasma Method of producing glycine-stabilized, lyophilized plasma

2011-04-26

2011-04-26

Saucier, Sandra (Department: 1651)

Drug, bio-affecting and body treating compositions

Extract, body fluid, or cellular material of undetermined...

Blood

Reexamination Certificate

active

07931919

ABSTRACT:
The invention is directed to stabilized whole-cell plasma, which retains the integrity and overall stability of the proteins and other macromolecules of the plasma. Stabilization is accomplished by the addition of glycine to plasma which allows for stabilization prior to freeze drying. Glycine, in the presence of the salt concentration in the plasma, does not recrystallize and acts as a superior stabilizer for the lyophilized plasma. The stability of the freeze dried plasma may be further improved by addition of protectants including calcium chloride, trisodium citrate, hydroxyethyl starch, ammonium sulfate and citric acid to maintain physiologic pH. Superior stability for a wide variety of plasma proteins and functions is shown. A system for the large scale preparation of sterile lyophilized plasma is also provided.

REFERENCES:
patent: 4579735 (1986-04-01), Heimburger et al.
Hellstern et al., “Manufacture and in vitro characterization of a solvent/detergent-treated human plasma”, Vox Sanguinis 63 (3) : 178-185 (1992).

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