Abstract: The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1) or programmed death receptor Ligand 1 (PD-L1), and method for preparing the same. The disclosed formulations are free of sugar or sugar alcohol and stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Abstract: The present invention discloses a stable buffer free formulation of anti-PD1/anti-PD-L1 antibody, comprising an anti-PD1 or an anti-PD-L1 antibody, water, mannitol and surfactant, and stabilized at a pH of about 5.0-about 6.0. The disclosed antibody formulation is a liquid formulation and can be lyophilized. Further, the said formulation is also suitable for different mode of administration such as subcutaneous/intravenous, for therapeutic use.

Abstract: The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1)/programmed death receptor Ligand 1 (PD-L1), and method for preparing the same. The disclosed formulations stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Abstract: The present invention relates to pharmaceutical formulations of antibodies and antigen-binding fragments against human programmed death receptor-1 (PD-1)/programmed death receptor Ligand 1 (PD-L1), and method for preparing the same. The disclosed formulations are free of chelators and stabilizes anti-PD1/anti-PD L1 antibody from lower to higher concentrations rendering it suitable for different modes of administration (subcutaneous/intravenous).

Abstract: The present invention discloses a stable formulation of an ?4?7 antibody, wherein the formulation comprises ?4?7 antibody, amino acid, a mono carboxylic acid or dicarboxylic acid or dicarboxylic acid, and surfactant. The disclosed antibody formulations are liquid high concentration formulations that are also suitable for different mode of administration (subcutaneous/intravenous). The disclosed formulations exhibit stability under various accelerated stress conditions.

Abstract: 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.

Abstract: 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.

Abstract: The present invention discloses a pharmaceutical formulation of antibody that binds to interleukin. The invention also discloses methods of making the same. The formulation composition comprises a weak organic acid and organic base buffer and pharmaceutically acceptable excipients. The said composition stabilizes the antibody by controlling aggregation, degradation, oxidation and formation of charge variants. The disclosed antibody formulations are liquid formulations that are also suitable for lyophilization.

Abstract: The present invention discloses a buffer free formulation of high concentration ?4?7 antibody, comprising ?4?7 antibody, water, and surfactant, and stabilized at a pH of 6.0-6.5. The disclosed antibody formulations are liquid formulations and can be lyophilized. Further, the said formulations are also suitable for different mode of administration such as subcutaneous/intravenous, for therapeutic use.

Abstract: The present invention discloses an optimal lyophilization method to prepare a room-temperature-stable freeze-dried formulation of an anti-?4?7 antibody wherein the lyophilized anti-?4?7 antibody formulation obtained from the said method exhibits stability at room temperature for at least three months and reconstituted anti-?4?7 antibody formulation exhibits stability at room temperature at least for 24 hours.

Abstract: The present invention discloses a stable pharmaceutical formulation of an ?4?7 antibody, wherein the formulation contains buffer, PEG, salt, amino acid and surfactant and wherein the formulation is devoid of sugar and/or sugar alcohols. The disclosed antibody formulations are liquid formulations, and are also suitable to be formulated as a lyophilized powder.

Abstract: The free thiol group present in free cysteines in recombinant therapeutic antibodies are reactive to process components and generates product variants during early stages of biosimilar development. Free thiol group present on the structural motifs, especially in the complementary determining regions (CDR), support maximal antigen binding capability. Product variants associated with these free thiol groups are detrimental for safety and efficacy of these therapeutic antibodies. Methods to identify and characterize various thiol variants an antibody composition is provided and an anti-IL-17A IgG1 composition having these thiol variants are described.

Abstract: A method and system for determining device presence in a mesh network and for directing messages to a destination within the network is presented. Node devices periodically issue device presences messages that are propagated through the network. Receiving devices store and analyze data from received device presence messages to determine presence and nodal distance to other nodes. Device presence message data can be used to route directed messages on the network and for network analysis.

Abstract: The present invention discloses a high concentration formulation of an ?4?7antibody, comprising ?4?7antibody, amino acid(s), salt and surfactant, wherein the free amino acid(s) are hydrophobic amino acids and/or basic amino acid (s). The disclosed antibody formulations are liquid formulations that are also suitable for different mode of administration (subcutaneous/intravenous) and exhibits stability under various accelerated conditions.

Abstract: 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.

Abstract: The present invention discloses a method for the identification and absolute quantification of peptide based impurities in a protein/antibody composition using high resolution mass spectrometry. The method utilizes synthetic peptides for plotting a standard calibration curve which is, in turn, used for the absolute quantification of the impurities. In particular, the method is utilized for quantification of signal peptide remnants in heterogeneous unpurified or partially purified protein samples, comprising a complex mixture of proteins, with high sensitivity using unlabeled synthetic peptides.

Abstract: A method and system for determining device presence in a mesh network and for directing messages to a destination within the network is presented. Node devices periodically issue device presences messages that are propagated through the network. Receiving devices store and analyze data from received device presence messages to determine presence and nodal distance to other nodes. Device presence message data can be used to route directed messages on the network and for network analysis.

Abstract: 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.

Abstract: 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.

Abstract: 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.