The present invention relates to an improved method for peak fractionation and eluate collection during chromatography for purification of a human therapeutic antibody.

The present invention provides for purification of liraglutide using selective ion-pairing agents in the reversed phase-high performance liquid Chromatography, for purifying crude liraglutide from closely related impurities.

The present invention provides for purification of liraglutide using selective ion-pairing agents in the reversed phase-high performance liquid Chromatography, for purifying crude liraglutide from closely related impurities.

Methods of producing multiple protein products from blood-based materials including alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins are described herein. The inventive methods include steps of fractionation that utilize a combination of salt and organic solvent. Advantageously, the inventive methods are simple and produce alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins in high yields. The sequence of process steps can be selected to obtain multiple products from various in-process materials, such as supernatants, pastes, chromatography flow-though, and chromatography washes.

Methods of producing multiple protein products from blood-based materials including alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins are described herein. The inventive methods include steps of fractionation that utilize a combination of salt and organic solvent. Advantageously, the inventive methods are simple and produce alpha-1-proteinase inhibitor, gamma globulin, albumin, and other proteins in high yields. The sequence of process steps can be selected to obtain multiple products from various in-process materials, such as supernatants, pastes, chromatography flow-though, and chromatography washes.

The present invention discloses rapid and cost-effective method of de-glycosyation of a glycoprotein, wherein, glycoprotein is combined with anionic surfactant and reducing agent and non-ionic surfactant in order to obtain stable denatured glycoprotein. An endoglycosidase is further added to denatured glycoprotein to cleave N-linked glycans in order to obtain de-glycosylated protein. A rapid tool for assessing the protein conformation by partial de-glycosylation is also presented wherein the partial de-glycosylated protein is analysed using capillary electrophoresis (CE-SDS).

The present invention discloses rapid and cost-effective method of de-glycosyation of a glycoprotein, wherein, glycoprotein is combined with anionic surfactant and reducing agent and non-ionic surfactant in order to obtain stable denatured glycoprotein. An endoglycosidase is further added to denatured glycoprotein to cleave N-linked glycans in order to obtain de-glycosylated protein. A rapid tool for assessing the protein conformation by partial de-glycosylation is also presented wherein the partial de-glycosylated protein is analysed using capillary electrophoresis (CE-SDS).

Methods are disclosed for producing highly purified recombinant human insulin (RHI) having a purity of 99.0% (w/w) or greater, a Total Impurity (not including the related substance desamido Asn.sup.A21-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.

Methods are disclosed for producing highly purified recombinant human insulin (RHI) having a purity of 99.0% (w/w) or greater, a Total Impurity (not including the related substance desamido Asn.sup.A21-RHI, as specified by USP) of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less. Also disclosed are API compositions of highly purified RHI having a purity of 99.0% (w/w) or greater, a Total Impurity of 0.8% (w/w) or less, and an impurity C of 0.1% (w/w) or less.

The present invention relates to a separation method comprising: i) providing an aqueous solution comprising a target compound; ii) applying a separation step to the aqueous solution, thereby providing a plurality of fractions of the aqueous solution: iii) determining a concentration parameter indicating a concentration of the target compound in at least part of the fractions; iv) determining a nuclear magnetic resonance (NMR) parameter by applying an NMR measurement to the fractions, the NMR parameter indicating a nuclear magnetic spin relaxation in said at least part of the fractions; and v) determining a target parameter of said at least part of the fractions based on the concentration parameter and the nuclear magnetic resonance parameter. The present invention further relates to separation systems, uses, preparations, and methods related thereto.