Abstract: The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.

Abstract: The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.

Abstract: The present invention relates to purification process of pharmacologically active cytotoxic T lymphocyte-associated 4-immunoglobulin (CTLA4-lg) fusion protein by using three column chromatography steps that provides purified form of the fusion protein, substantially free of misfolded species, charge variants and aggregates. A method for purifying a fusion protein from a protein mixture comprising a fusion protein and high molecular weight (HMW) impurity.

Abstract: The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.

Abstract: The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention provides cytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.

Abstract: The present invention is directed to the use of anion exchange chromatography to produce a CTLA4-Ig fusion protein with improve glycan.

Abstract: The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention provides cytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.

Abstract: The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.

Abstract: The present invention relates to novel liquid formulations comprising pharmacologically active fusion protein. The present invention discloses the use of histidine buffer in combination with other excipients to stabilize the fusion protein by lowering the product related impurities. In another aspects invention provides a formulation of fusion protein with low viscosity.

Abstract: The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.

Abstract: The present invention provides a method for reducing the protein aggregation by adjusting the pH below 6.0 of liquid formulation comprising the antibody or fusion protein. The present invention also provides methods for storing the pre-formulation for longer period without using any sugar or additives which can be utilized for preparation of liquid or lyophilized formulation.

Abstract: The invention provides a process of purification of antibody or fusion protein from protein mixture comprising product and process related impurities. The process provides the use of hydroxyapatite chromatography for the separation of low molecular weight impurities and basic variants. In addition, invention further provides a scalable purification process to remove product and process related impurities.

Abstract: A process for purification of antibody or fusion protein by affinity chromatography wherein the elution is performed with high salt concentration which reduce turbidity in protein mixture during neutralization steps. The present invention provides an improved process of purifying antibodies through affinity chromatography using high salt-based elution.

Abstract: A process for purification of antibody or fusion protein through anion exchange chromatography to produce an antibody or fusion protein which is substantially free of at least one of the product-related impurities.

Abstract: The present disclosure describes pharmaceutically stable high concentration liquid formulations of antibody. Such formulations comprise, in addition to the antibody, at least one anti-aggregating agent selected from arginine or lysine, buffer and poloxamer 188. In addition, the present disclosure provides high concentrated antibody formulation having high monomer, low aggregates and desirable viscosity.