Dr. Reddy's Laboratories, Incorporated

Murali Jayaraman

Anuja Chandrasekar

Lakshmi Kanakadurga M

Pravin Nair

Navneet Kaur

Deepak Thumbrahalli

The present invention discloses a stable pharmaceutical formulation of an antibody, wherein the formulation contains buffer, surfactant and sugar, and wherein the formulation is devoid of free amino acids and salts.

Stable formulations of therapeutic antibody

The present invention discloses a stable pharmaceutical formulation of a fusion protein, wherein the formulation contains buffer, sugar, amino acid and surfactant, and optionally includes salts. The disclosed fusion protein formulations are liquid formulations that are also suitable for lyophilization.

Stable fusion protein formulation

The present invention discloses a stable pharmaceutical formulation of an antibody, wherein the formulation contains buffer, surfactant, sugar, and optionally contains a free amino acid. The disclosed formulation is stable at 50° C. for two weeks. In addition, the formulation maintains at least 96% of the antibody in monomeric form under above said storage conditions.

Antibody formulation

The present invention discloses a stable pharmaceutical formulation of an antibody, wherein the formulation contains buffer, surfactant and salt, and wherein the formulation is devoid of free amino acids. The disclosed antibody formulations are liquid formulations that are also suitable for lyophilization.

Stable antibody formulation

The present invention provides a stable liquid formulation of an antibody in phosphate-amino acid based dual buffer system. The antibody formulated in phosphate-amino acid based dual buffer system imparts optimum stability to the antibody, at lower as well as higher concentrations. Further, the antibody formulated in phosphate-amino acid based buffer system has low viscosity and is suitable for therapeutic administration of high concentrations of antibody.

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Kancheepuram, India

Murali Jayaraman