A process for providing a mono-PEGylated protein composition is provided. The process is particularly suitable for providing mono-PEGylated erythropoietin composition. The process comprises subjecting a mixture comprising non-PEGylated, mono-PEGylated and oligo-PEGylated to a hydrophobic interaction chromatography process.

A process for transferring a method from a starting system to a target system in liquid chromatography, in particular in high performance liquid chromatography, is described. A first chromatogram of the method carried out on the starting system is available or determined. The method developed for the starting system is carried out on the target system without any change in its physical parameters, and a second chromatogram is thereby determined. The two chromatograms of the starting system and the target system are compared, and measures for adjusting the physical system parameters of the target system are derived from the deviations.

A liquid chromatography reagent kit includes a mobile phase anti-adsorption concentrate. The mobile phase anti-adsorption concentrate includes a first solvent, a buffer, an acid-base regulating reagent, and an anti-adsorption reagent. A ratio of a molarity of the buffer to a molarity of the acid-base regulating reagent is 400:1 to 1:1. A ratio of the molarity of the buffer to a molarity of the anti-adsorption reagent is 100:1 to 1:2.

A first solution is supplied from a first pump. A second solution is supplied from a second pump. A flow path from the first pump and the second pump to a column is switched between a first flow path and a second flow path. In the first flow path, a first mixer is located upstream of an injection part for a sample, and the second mixer is located downstream of the injection part. In the second flow path, the first mixer and the second mixer are located upstream of the injection part. The first flow path is formed in a first mode in which the sample is diluted before introduction into the column. The second flow path is formed in a second mode in which the sample is not diluted before introduction into the column.

Provided is a separation method for amine, the separation method including performing liquid chromatography, wherein a separating agent in which a ligand having a crown ether-like cyclic structure is supported on a carrier is used as a stationary phase, and wherein a mobile phase contains an aqueous solution of at least one salt of a hydrophobic anion selected from the group consisting of a salt of a chaotropic anion and a salt of a hydrophobic organic acid.

The present invention relates to: a method of purifying an antibody, which can prepare a desired antibody with high purity and high quality by removing impurities without using an expensive protein A column, and particularly, can purify an antibody in a high yield while greatly reducing an amount (volume) of a buffer used in an elution process; and an antibody prepared by the method.

Methods and systems are provided to improve consistency and robustness in chromatography, for example, in operations of multi-column chromatography systems.

The present disclosure relates to the determination of analytes in a sample using chromatography. The present disclosure provides methods of separating an analyte from a sample. A mobile phase is flowed through a chromatography column. The mobile phase includes about 0.005% (v/v) to about 2.50% (v/v) difluoroacetic acid and less than about 100 ppb of any individual impurity, especially metal impurities. A sample including the analyte is injected into the mobile phase. The analyte is separated from the sample.

The present disclosure relates to methods of modifying complex extracts such that components or mixtures of components are selectively removed or added, thus providing a complex mixture that does not naturally occur with a refined or a tuned therapeutic or nutraceutical effect. In various aspects, the complex extract can be an extract obtained from one or more plants, e.g., an extract obtained from green tea leaves. The present disclosure pertains to compositions obtained by the disclosed methods, nutraceutical compositions comprising same, pharmaceutical compositions comprising same, and methods of treating various conditions, including physiological dysfunctions associated with elevated reactive oxygen species and/or inflammatory molecule, e.g., TNFα, expression using same. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present disclosure.

A process for purifying a composition comprising water, a target substance, impurities and optionally cells, the process comprising the steps (A) and (B): (A) preparing a liquid feedstock by performing step (Ai) and/or (Aii) on the composition: (Ai) removing at least some of the cells from the composition; (Aii) concentrating the composition by removing water therefrom; and (B) passing the liquid feedstock through an apparatus comprising at least two processing units, each such unit producing a product stream containing purified target substance and optionally a waste stream comprising at least some of the impurities, wherein each unit comprises specified components (i) to (v). The units may be essentially the same except for a device they contain, leading to advantages in terms of simplicity, cost and ease of operation, lower risk of operator error, easier maintenance and lower inventory of spare parts.