Abstract: The present invention relates to the field of chromatography. More closely, the invention relates to a chromatographic method for purification of proteins, such as Factor VIII, von Willebrand factor and Factor IX. The chromatographic method is performed on a matrix comprising an inner porous core and outer porous lid surrounding said core.

Abstract: The present invention relates to the field of chromatography. More closely, the invention relates to a chromatographic method for purification of proteins, such as Factor VIII, von Willebrand factor and Factor IX. The chromatographic method is performed on a matrix comprising an inner porous core and outer porous lid surrounding said core.

Abstract: The present invention relates to the field of chromatography. More closely, the invention relates to a chromatographic method for purification of plasmaproteins, such as Factor VIII, von Willebrand factor and Factor IX. The chromatographic method is performed on a matrix comprising an inner porous core and outer porous lid surrounding said core.

Abstract: The invention discloses a separation matrix comprised of porous spherical particles to which antibody-binding protein ligands have been covalently immobilized, wherein the density of said ligands is in the range of 10.5-15 mg/ml and the volume-weighted median diameter of said particles is in the range of 30-55 ?m.

Abstract: The invention discloses a separation matrix for purification of biological particles, comprising a plurality of particles having a porous core entity and a porous shell entity covering the core entity, wherein the core entity comprises at least 50 micromole/ml primary amines present on covalently attached ligands displaying at least two primary amines per ligand and the shell entity comprises less than 20 micromole/ml primary amines The invention further discloses a method of purifying biological particles and a method of manufacturing a separation matrix.

Abstract: The present invention relates to a chromatography system and a method therefor. The chromatography system comprising an inlet port (102) for receiving a sample, an outlet port (106) for delivering the sample, a detector (201), a column (104), and a valve (202) in fluid communication with the inlet port, the outlet port, the detector, and the column. The valve (202) comprises a first position (304) wherein the inlet port is in fluid communication with the outlet port via a first fluid path comprising the detector and the column, wherein the detector is arranged upstream the column. The valve comprises a second position (404) wherein the inlet port is in fluid communication with the outlet port via a second fluid path comprising the detector and the column, wherein the detector is arranged downstream the column.

Abstract: The present invention relates to a method for optimizing a bioprocess purification system comprising a bioreactor configured to provide a harvest comprising a target composition, and a purification process arranged downstream the bioreactor and being configured for purification of the harvest to produce a target product having a desired characteristics. The method comprising: a) detecting (32) at least one quality attribute indicative of characteristics of the target product in a downstream process, b) identifying (33) correlations between the at least one quality attribute measured in the downstream process and parameters to control a cell culture process in the bioreactor, and c) controlling (34) the cell culture process to meet the desired characteristics based on the identified correlations, whereby the target characteristics is within a pre-determined range.

Abstract: There is provided a method and a corresponding system for determining binding capacities of a chromatography column. The method includes detecting a feed signal representative of the composition of a feed material provided to the inlet of the column. The method further includes detecting an effluent signal representative of the composition of the effluent from the column. The method further includes using the feed signal and the effluent signal to determine binding capacities of the column.

Abstract: A method of continuous separation of a plasmid from a process feed in an apparatus with at least three chromatography columns packed with separation matrix particles, wherein while one chromatography column is loaded with the process feed, another chromatography column is eluted with an eluent to recover the separated plasmid, and yet another chromatography column is eluted with a further eluent to remove contaminants.

Abstract: The present invention relates to a method for determining operational status of a chromatography column (1; 39, 47, 59; 107, 109, 111, 113), comprising detecting a feed signal (21; 201) representative of the composition of a feed material provided to the inlet of the column; detecting the UV absorbance in the feed material, detecting an effluent signal (23; 203, 205, 207, 209) representative of the composition of the effluent from the column; and using the feed signal and the effluent signal to determine operational status of the column. The feed signal is generated using a first UV detector having a first UV cell pathlength operating at a first UV wavelength and in the effluent signal is generated using a second UV detector having a second UV cell pathlength operating at a second UV wavelength.

Abstract: The present invention relates to a method for monitoring operational status in continuous chromatography configured to operate with at least three columns adapted for cyclic use for continuous purification of a target product when feeding the continuous chromatography with a sample containing the target product. The method comprises detecting (81) at least one parameter indicative of a selected function in the continuous chromatography, performing (82) real time trend analysis of the detected parameter to identify a deviating behaviour of the selected function, and initiate (83) actions to eliminate or reduce the effect of the identified deviating behaviour where by the performance of the continuous chromatography is maintained.

Abstract: The present invention relates to a method for controlling a bioprocess purification system comprising a continuous chromatography configured to operate with at least three columns and configured for cyclic operation, wherein the continuous purification is performed on a sample comprising a target product having desired characteristics. The method comprises detecting (82) at least one parameter indicative of characteristics of the target product, performing (83) real time trend analysis of each detected at least one parameter to identify a deviation from the desired characteristics of the target product, and controlling (84) the bioprocess purification system to meet the desired characteristics based on the identified deviation, whereby the target characteristics is within a pre-determined range.

Abstract: The present invention relates to a chromatography system and a method therefor. The chromatography system comprising an inlet port (102) for receiving a sample, an outlet port (106) for delivering the sample, a detector (201), a column (104), and a valve (202) in fluid communication with the inlet port, the outlet port, the detector, and the column. The valve (202) comprises a first position (304) wherein the inlet port is in fluid communication with the outlet port via a first fluid path comprising the detector and the column, wherein the detector is arranged upstream the column. The valve comprises a second position (404) wherein the inlet port is in fluid communication with the outlet port via a second fluid path comprising the detector and the column, wherein the detector is arranged downstream the column.

Abstract: The invention discloses a separation matrix comprised of porous spherical particles to which antibody-binding protein ligands have been covalently immobilized, wherein the density of said ligands is in the range of 10.5-15 mg/ml and the volume-weighted median diameter of said particles is in the range of 30-55 ?m. The invention further discloses a method of separation of antibodies by affinity chromatography which employs the said separation matrix within a chromatography column.

Abstract: The present invention relates to the field of chromatography. More closely, the invention relates to a chromatographic method for purification of plasmaproteins, such as Factor VIII, von Willebrand factor and Factor IX. The chromatographic method is performed on a matrix comprising an inner porous core and outer porous lid surrounding said core.

Abstract: The invention discloses a separation matrix for purification of biological particles, comprising a plurality of particles having a porous core entity and a porous shell entity covering the core entity, wherein the core entity comprises at least 50 micromole/ml primary amines present on covalently attached ligands displaying at least two primary amines per ligand and the shell entity comprises less than 20 micromole/ml primary amines The invention further discloses a method of purifying biological particles and a method of manufacturing a separation matrix.

Abstract: A method for determining binding capacities of a chromatography column (1; 39, 47, 59; 107, 109, 111, 113), comprising: detecting a feed signal (21; 201) representative of the composition of a feed material provided to the inlet of the column; detecting an effluent signal (23; 203, 205, 207, 209) representative of the composition of the effluent from the column; using the feed signal and the effluent signal to determine binding capacities of the column. And a method for controlling a chromatography system comprising at least one column, comprising the steps of: determining binding capacities of the at least one chromatography column according to above; and controlling the start and stop of the different chromatography process steps according to the determined binding capacities.