Methods and systems for removing gases and/or pressure formed during the sterilization, e.g., the gamma irradiation, of prepacked chromatography systems (column plus attached tube and valve set) are described. The methods include purging the gas and/or pressure through specially designed tube and valve sets without breaching the sterility of the prepacked sterile chromatography system. The systems include a sterile or aseptic pre-packed chromatography column including a column having an inlet and an outlet, a tubing and valve set attached to the inlet and the outlet, and a pump configured to pump sterile or aseptic liquid from the fluid source along the tubing and valve set, into the column tube inlet and out of the column tube outlet along a first flow path, thereby removing any entrapped gas and/or pressure from the chamber.

Methods and systems for removing gases and/or pressure formed during the sterilization, e.g., the gamma irradiation, of prepacked chromatography systems (column plus attached tube and valve set) are described. The methods include purging the gas and/or pressure through specially designed tube and valve sets without breaching the sterility of the prepacked sterile chromatography system. The systems include a sterile or aseptic pre-packed chromatography column including a column having an inlet and an outlet, a tubing and valve set attached to the inlet and the outlet, and a pump configured to pump sterile or aseptic liquid from the fluid source along the tubing and valve set, into the column tube inlet and out of the column tube outlet along a first flow path, thereby removing any entrapped gas and/or pressure from the chamber.

The present invention is within the field of chromatography. More precisely, it relates to a novel chromatography medium, namely a hydrophobic medium provided with different lids excluding molecules over a certain size due to the porosity of the hydrophobic medium and/or the porosity of the lid. The invention also relates to use of the separation medium for purification of large molecules, which do not enter the separation medium, as well as small molecules, which enter the separation medium and are eluted from there.

The present invention is within the field of chromatography. More precisely, it relates to a novel chromatography medium, namely a hydrophobic medium provided with different lids excluding molecules over a certain size due to the porosity of the hydrophobic medium and/or the porosity of the lid. The invention also relates to use of the separation medium for purification of large molecules, which do not enter the separation medium, as well as small molecules, which enter the separation medium and are eluted from there.

A chromatographic media for separating bio-polymers, the chromatographic media having cationic exchange properties and anionic exchange properties, the chromatographic media comprising: (a) non-porous substrate particles including an organic polymer, the substrate particles having a neutral hydrophilic layer at a surface of the non-porous substrate particles, in which the neutral hydrophilic layer is configured to reduce a binding of the bio-polymers directly to the non-porous substrate particles compared to a binding of the bio-polymer to the non-porous substrate particles without the neutral hydrophilic layer; (b) a charged first ion exchange layer bound to the substrate particles on top of the hydrophilic layer, the first ion exchange layer comprising first ion exchange groups; and (c) a charged second ion exchange layer bound to the substrate particles on top of the first ion exchange layer.

A chromatographic media for separating bio-polymers, the chromatographic media having cationic exchange properties and anionic exchange properties, the chromatographic media comprising: (a) non-porous substrate particles including an organic polymer, the substrate particles having a neutral hydrophilic layer at a surface of the non-porous substrate particles, in which the neutral hydrophilic layer is configured to reduce a binding of the bio-polymers directly to the non-porous substrate particles compared to a binding of the bio-polymer to the non-porous substrate particles without the neutral hydrophilic layer; (b) a charged first ion exchange layer bound to the substrate particles on top of the hydrophilic layer, the first ion exchange layer comprising first ion exchange groups; and (c) a charged second ion exchange layer bound to the substrate particles on top of the first ion exchange layer.

The present invention is related to a separating agent for the purification of human insulin, ensuring that human insulin can be recovered in high yield when isolating human insulin from a solution containing human insulin and a specific insulin under specific liquid chromatography separation conditions by using the separating agent.

The present disclosure relates to methods, compositions and kits useful for the enhanced pH gradient cation exchange chromatography of a variety of analytes. In various aspects, the present disclosure pertains to chromatographic elution buffer solutions that comprise a first buffer salt, a second buffer salt, a third buffer salt, and fourth buffer salt. The first buffer salt may be, for example, a diprotic acid buffer salt, the second buffer salt may be, for example, a divalent buffer salt with two amine groups, the third buffer salt may be, for example, a monovalent buffer salt comprising a single amine group, and the fourth buffer salt may be, for example, a zwitterionic buffer salt. Moreover, the buffer solution has a pH ranging from 3 to 11.

The present disclosure relates to methods, compositions and kits useful for the enhanced pH gradient cation exchange chromatography of a variety of analytes. In various aspects, the present disclosure pertains to chromatographic elution buffer solutions that comprise a first buffer salt, a second buffer salt, a third buffer salt, and fourth buffer salt. The first buffer salt may be, for example, a diprotic acid buffer salt, the second buffer salt may be, for example, a divalent buffer salt with two amine groups, the third buffer salt may be, for example, a monovalent buffer salt comprising a single amine group, and the fourth buffer salt may be, for example, a zwitterionic buffer salt. Moreover, the buffer solution has a pH ranging from 3 to 11.

A process of obtaining a purified geometric isomer of an unsaturated macrocyclic compound is disclosed herein. The process is effected by contacting an ion exchange medium comprising silver ions with a mixture comprising at least one geometric isomer of the unsaturated macrocyclic compound, to thereby obtain at least one fraction comprising the purified geometric isomer of the macrocyclic compound. A system configured for performing the process is also disclosed.