Abstract: The present invention relates to a preparative chromatography system (200, 500, 800) and a chromatography process (400, 700) adapted to repetitive cycling of chromatography volumes. The system (200, 500, 800) comprises at least two upstream pumps (203a, 803a, 203b, 803b) and separate flow paths (220) from process liquid sources to the chromatography device (200, 500, 800). The system (200, 500, 800) is arranged to prime one flow path (220) with one process liquid while providing another process liquid to the chromatography device and thereby minimizing the hold-up volume of the system (200, 500, 800).

Abstract: The present invention relates to a method for monitoring operational status in a column capture chromatography system configured for cyclical repetitive purification performed on a volume of sample feed comprising at least one product configured to be captured in the column during loading. The method comprises: performing (51) a purification cycle; measuring (52) at least one parameter during the purification cycle indicative of breakthrough of the at least one captured product after the column during loading of sample feed; when breakthrough is detected, reducing (56a) the amount of sample feed loaded during loading in the next purification cycle; and repeating the steps to perform another purification cycle. Each purification cycle comprising: loading an amount of sample feed onto the column, washing the column and eluting the at least one product.

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: The present invention relates to a method for estimating performance of a bioprocess material when used in a bioprocess system. The bioprocess material comprising at least two ingredients, each having data properties.

Abstract: The invention discloses a method for correcting a baseline in a chromatogram obtained using a buffer with at least one UV-absorbing component which is a weak acid or a weak base.

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 invention discloses a method for correcting a baseline in a chromatogram obtained using a buffer with at least one UV-absorbing component which is a weak acid or a weak base.

Abstract: A method of determining the relative component proportions of at least one each of: a buffer; an acid or a base; a solvent; and optionally a salt, for providing a liquid mixture of pre-defined pH and ionic strength, wherein the relative component proportions are determined using the equation of Debye-Hückel, wherein the ion size parameter a in the Debye-Hückel equation is determined as the weighted mean ion size of all species contributing to the ionic strength of the liquid mixture, and wherein the ionic strength of each species is used as weighting parameter. The present method is also applicable in a method of providing a liquid mixture. Further there is provided a buffer preparation device.

Abstract: The present invention relates to a separation matrix comprised of porous particles to which antibody-binding protein ligands have been immobilized, wherein the ligand density is in the range of 5.0-10 mg/ml; the gel phase distribution coefficient of the particles expressed as Kav for a dextran of size 110 kDa is above 0.65 and the median particle diameter is between 65-84 ?m. The carbohydrate material is preferably highly cross-linked agarose.

Abstract: The present invention relates to a liquid mixture comprising a first polymer, which is a poly(acid), a second polymer, which is a poly(ether), and at least one salt, wherein the molecular weight of the poly(acid) is in the range of 1000-100,000 Da. The second polymer is selected to be capable of forming immiscible aqueous phases in the presence of the poly(acid) and salt. The poly(acid) may be selected from the group consisting of poly(acrylic acid) and poly(methacrylic acid), and the second synthetic polymer may comprise ethylene oxide. The invention may be used for separation of biomolecules, cells or particles.

Abstract: The present invention relates to separation matrices comprising base matrices with first ligands comprising hydrophobic functions covalently bound to said base matrices and with extenders covalently bound to said base matrices, said extenders comprising second ion exchange ligands.

Abstract: A method of determining the relative component proportions of at least one each of: a buffer; an acid or a base; a solvent; and optionally a salt, for providing a liquid mixture of pre-defined pH and ionic strength, wherein the relative component proportions are determined using the equation of Debye-Hückel, wherein the ion size parameter a in the Debye-Hückel equation is determined as the weighted mean ion size of all species contributing to the ionic strength of the liquid mixture, and wherein the ionic strength of each species is used as weighting parameter. The present method is also applicable in a method of providing a liquid mixture. Further there is provided a buffer preparation device.

Abstract: The present invention relates to a liquid mixture comprising a first polymer, which is a poly(acid), a second polymer, which is a poly(ether), and at least one salt, wherein the molecular weight of the poly(acid) is in the range of 1000-100,000 Da. The second polymer is selected to be capable of forming immiscible aqueous phases in the presence of the poly(acid) and salt. The poly(acid) may be selected from the group consisting of poly(acrylic acid) and poly(methacrylic acid), and the second synthetic polymer may comprise ethylene oxide. The invention may be used for separation of biomolecules, cells or particles.

Abstract: The present invention relates to a process of isolating one or more target compounds, wherein the clarification of feed is performed using partitioning in a multiphase system comprising a first polymer, which is a synthetic poly(acid), a second synthetic polymer, which is a poly(ether), and at least one salt, which clarification is followed by at least one step of affinity chromatography. The molecular weight of the poly(acid) may be in the range of 1000-100,000 Da. The target compound is preferably a biomolecule, such as a monoclonal antibody.

Abstract: The present invention relates to a separation matrix comprised of porous particles to which antibody-binding protein ligands have been immobilised, wherein the ligand density is in the range of 5.0-10 mg/ml; the gel phase distribution coefficient of the particles expressed as Kav for a dextran of size 110 kDa is above 0.65 and the median particle diameter is between 65-84 ?m. The carbohydrate material is preferably highly cross-linked agarose.