Formulations and methods for contemporaneous stabilization of active proteins during spray drying and storage
AssigneeVelico Medical, Inc.
InventorsQiyong Peter Liu, Junqing Cui, Rud Karly Lucien, Ryan Carney, Jihae Sohn, Michelle Arya
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Abstract
A method of treatment of plasma with a physiologically compatible spray dry stable acidic substance (SDSAS) prior to or contemporaneously with spray drying of the plasma that results in greater recovery and greater long-term stabilization of the dried plasma proteins as compared to spray dried plasma that has not be subject to the formulation method of the present invention, as well as compositions related to plasma dried by the methods of the present invention.
Claims39
A method of producing a dried formulated plasma, the method comprising providing:
- i) plasma,
- ii) one or more physiologically compatible stable acidic substances, wherein said one or more stable acidic substances is an acid or acidic salt that effectuates a pH and is physiologically suitable for addition to plasma being dried or physiologically suitable for subjects into which reconstituted plasma is transfused, wherein when plasma and one or more stable acidic substances are combined, the combination creates a formulated plasma, and
- iii) a plasma drying system for drying the formulated plasma
- to thereby create a dried formulated plasma, wherein the concentration of the stable acidic substance is in a range between about 0.001 and about 0.050 mmol/ml in the plasma.
A method of producing spray dried formulated plasma, the method comprising:
- a) contacting i) plasma with ii) one or more spray dry stable acidic substances (SDSAS), wherein said one or more SDSAS is an acid or acidic salt that effectuates a pH and is physiologically suitable for addition to plasma being spray dried or physiologically suitable for subjects into which reconstituted plasma is transfused, to thereby create a formulated plasma so that the pH of formulated plasma is between about 5.5 and 7.2, and
- b) spray drying the formulated plasma to thereby obtain spray dried formulated plasma.
Dependencies are inferred from the claim text.