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, Abdul W. Khan
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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 compostions related to plasma dried by the methods of the present invention.
Claims30
A method of producing a formulated plasma for spray drying, the method comprising:
- a) combining one or more stable acidic substances with plasma, wherein the concentration of the stable acidic substance is in a range between about 0.001 mmol/ml and about 0.050 mmol/ml, wherein said one or more stable acidic substances is an acid or acidic salt that effectuates a pH, to thereby create a formulated plasma.
A method of spray drying plasma, the method comprising:
- a) combining one or more stable acidic substances and plasma, wherein the concentration of the stable acidic substance is in a range between about 0.001 mmol/ml and about 0.050 mmol/ml, wherein said one or more stable acidic substances is an acid or acidic salt that effectuates a pH, to thereby create a formulated plasma;
- and
- b) spray drying said formulated plasma in a plasma spray drying system to thereby obtain spray dried formulated plasma.
A method of producing plasma suitable for transfusion into a recipient, the method comprising:
- a) combining one or more stable acidic substances and plasma, wherein the concentration of the stable acidic substance is in a range between about 0.001 mmol/ml and about 0.050 mmol/ml, wherein said one or more stable acidic substances is an acid or acidic salt that effectuates a pH, to thereby create a formulated plasma;
- b) spray drying said formulated plasma in a plasma spray drying system to thereby obtain spray dried formulated plasma;
- and
- c) reconstituting the spray dried formulated plasma to thereby obtain reconstituted plasma suitable for transfusion into a recipient.
A method of producing plasma suitable for transfusion into a recipient, the method comprising:
- a) combining one or more stable acidic substances and plasma, wherein the concentration of the stable acidic substance is in a range between about 0.001 mmol/ml and about 0.050 mmol/ml, wherein said one or more stable acidic substances is an acid or acidic salt that effectuates a pH, to thereby create a formulated plasma;
- b) spray drying said formulated plasma in a plasma spray drying system to thereby obtain spray dried formulated plasma;
- c) storing the spray dried formulated plasma;
- and
- d) reconstituting the spray dried formulated plasma to thereby obtain reconstituted plasma suitable for transfusion into a recipient.
A method of producing spray dried formulated plasma, the method comprising providing:
- a) plasma,
- b) 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 spray dried or physiologically suitable for subjects into which reconstituted plasma is transfused, wherein the concentration of the stable acidic substance is in a range between about 0.001 and about 0.050 mmol/ml, and wherein when plasma and one or more stable acidic substances are combined, the combination creates a formulated plasma, and
- c) a plasma spray drying system for spray drying the formulated plasma to thereby create a spray dried formulated plasma.
Dependencies are inferred from the claim text.