Abstract: Provided herein are methods of separating host cell lipases from a production protein in chromatographic processes and methods of improving polysorbate-80 stability in a production protein formulation by separating host cell lipases from the production protein using chromatographic processes. Also provided herein are compositions comprising antibodies or antigen binding fragments thereof that bind to cytotoxic T lymphocyte associated antigen 4 (CTLA4). In another aspect, such compositions further comprise a reduced level of host cell proteins and/or increased level of polysorbate-80 (PS-80) stability.

Abstract: Provided herein are methods of separating host cell lipases from a production protein in chromatographic processes and methods of improving polysorbate-80 stability in a production protein formulation by separating host cell lipases from the production protein using chromatographic processes. Also provided are pharmaceutical compositions comprising less than 1 ppm of a host cell lipase.

Abstract: A process for solubilization and refolding of precursor insulin or insulin analogs from inclusion body isolates for use in the production of insulin or insulin analog is described.

Abstract: A process for solubilization and refolding of precursor insulin or insulin analogs from inclusion body isolates for use in the production of insulin or insulin analog is described.

Abstract: Provided are methods of refolding and purifying lipoproteins on a chromatography column. In particular methods of refolding ApoL1 polypeptides using a hydrophobic interaction column (HIC). The present invention provides methods for the purification of an active form of a human lipoprotein, such as ApoL1. More particularly, the present invention relates to a method for renaturing an inclusion body of proteins expressed in a large quantity in E. coli into an active form using a hydrophobic interaction column and removal of impurities, e.g., endotoxins.

Abstract: Disclosed are methods and processes utilizing multi-modal chromatography as a polishing step to separate heterogeneously charged (basic and acidic) aggregates and other impurities from partially a partially purified bulk product monoclonal antibody product. The resulting chromatographic process provides a scaleable production process that is cost effective and increases the productivity of the purification process over a platform utilizing a combination of anion and cation exchange chromatography to resolve heterogeneous aggregates.

Abstract: The present disclosure relates to processes useful in the isolation and purification of enfumafungin, which is classified as a triterpene glycoside antifungal compound and acts as a glucan synthase inhibitor. Enfumafungin has application in the treatment of conditions caused by fungal infection and is also useful as an intermediate in the preparation of other compounds useful as antifungal agents and/or inhibitors of (1,3)-?-D-glucan synthesis.

Abstract: The present disclosure relates to processes useful in the isolation and purification of enfumafungin, which is classified as a triterpene glycoside antifungal compound and acts as a glucan synthase inhibitor. Enfumafungin has application in the treatment of conditions caused by fungal infection and is also useful as an intermediate in the preparation of other compounds useful as antifungal agents and/or inhibitors of (1,3)-?-D-glucan synthesis.

Abstract: This invention provides a method for purifying a monomeric monoclonal antibody which comprises contacting the sample, wherein the sample comprises the monomeric monoclonal antibody, host cell impurities, dimers, and higher order aggregates, with a Protein A affinity chromatography column; eluting the monomeric monoclonal antibody from the Protein A affinity chromatography column with an elution buffer; and collecting one or more fractions of the monomeric monoclonal antibody to form a Protein A product pool, wherein the product pool comprises less than 5% higher order aggregate, and has a pH from about 3.2 to about 4.5, thereby purifying the monomeric monoclonal antibody from the sample. This invention also provides a method for purifying a monomeric monoclonal antibody which comprises eluting with acetate or citrate, optionally in the presence of amino acids.