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.
Claims20
A method of producing spray dried formulated plasma, the method comprising:
- a) providing i) plasma, ii) one or more physiologically compatible spray dry stable acidic substance (SDSAS), wherein said one or more SDSAS is selected from the group consisting of ascorbic acid, citric acid, gluconic acid, glycine hydrogen chloride (glycine-HCl), lactic acid and monosodium citrate, and iii) a spray drying system comprising a spray drier;
- b) treating the plasma by adjusting the pH of the plasma with the SDSAS by bringing the concentration of the SDSAS to between about 0.001 and about 0.050 mmol/mL in the plasma to create formulated plasma;
- c) drying the formulated plasma with the spray dryer to create spray dried formulated plasma, and determining that the spray dried formulated plasma has a recovery of von Willebrand factor activity at least 5 percentage points greater than the recovery of von Willebrand factor activity obtained from an otherwise identical spray dried plasma that has not undergone treatment with a SDSAS.
A method of producing spray dried plasma, the method comprising:
- a) contacting i) blood plasma contemporaneously with ii) one or more spray dry stable acidic substances (SDSAS), wherein said one or more SDSAS is selected from the group consisting of ascorbic acid, citric acid, gluconic acid, glycine hydrogen chloride (glycine-HCl), lactic acid and monosodium citrate, to create a plasma formulation so that the pH of plasma formulation is between about 5.5 and 7.2 and iii) spray drying the plasma formulation;
- b) wherein, when reconstituted, the reconstituted plasma formulation is determined to have a recovered amount of active von Willebrand's factor that is greater than that of the same plasma spray dried and reconstituted that has not been contacted with the spray dry stable acidic substance prior to spray drying.
Dependencies are inferred from the claim text.