Viscosity-reducing excipient compounds for protein formulations
AssigneeReform Biologics, LLC
InventorsDavid S. Soane, Philip Wuthrich, Rosa Casado Portilla, Robert P. Mahoney, Mark Moody
Life of this patent
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Abstract
The invention encompasses formulations and methods for the production thereof that permit the delivery of concentrated protein solutions. The inventive methods can yield a lower viscosity liquid formulation or a higher concentration of therapeutic or nontherapeutic proteins in the liquid formulation, as compared to traditional protein solutions.
Claims17
A liquid pharmaceutical formulation comprising a therapeutic antibody and a viscosity-reducing amount of caffeine, wherein (i) the viscosity of the formulation is at least about 50% less than the viscosity of a control formulation and is less than about 50 cP, (ii) the formulation contains at least about 100 mg/mL of the antibody, and (iii) the viscosity-reducing amount of caffeine is about 22 mg/ml or less;
- wherein the control formulation does not contain the caffeine but is otherwise identical on a dry weight basis to the liquid pharmaceutical formulation.
A liquid pharmaceutical formulation comprising a therapeutic antibody and a viscosity-reducing amount of caffeine, wherein (i) the viscosity of the formulation is at least about 50% less than the viscosity of a control formulation and is less than about 50 cP, (ii) the formulation contains at least about 200 mg/mL of the antibody, and (iii) the viscosity-reducing amount of caffeine is about 30 mg/ml or less;
- wherein the control formulation does not contain the caffeine but is otherwise identical on a dry weight basis to the liquid pharmaceutical formulation.
Dependencies are inferred from the claim text.