Method in Bioprocess System

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. The method comprises: i) obtaining (81) the data properties for the at least two ingredients used to produce the bioprocess material; ii) defining (82) procedures to process the at least two ingredients; iii) processing (83) the at least two ingredients according to the defined process parameters to obtain at least a product; iv) measuring (84) data properties of each product, v) calculating (85) data properties of each product based on the measured data properties of each product and/obtain or data properties from the at least two ingredients, and vi)if the product is the bioprocess material, processing (88) the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system, or vii) if the product is not the bioprocess material, treating the product as an intermediate material and repeating (87) steps iii)-vi) with each product as one of the at least two ingredients.

Method for Preparation of a Separation Matrix

A method for preparation of a separation matrix, comprising the steps of: a) providing a solid support and an alkali-stable ligand derived from an immunoglobulin-binding bacterial protein; b) reacting said alkali-stable ligand with said solid support to form a separation matrix having covalently coupled alkali-stable ligands; and c) washing said separation matrix having covalently coupled alkali-stable ligands with a wash solution comprising at least 10 mM of an alkali metal hydroxide.

Chromatography Beads, Production and Use Threreof

The present invention relates to chromatography beads, production and use thereof. More closely the invention relates to small, rigid and nan-permeable agarose beads suitable for example as stationary phase in high performance liquid chromatography (HPLC) for analyses of biomolecules, such as, peptides and proteins; and methods for producing such beads.

Purification of immunoglobulins

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 di-ameter is between 65 - 84 µm. The carbohydrate material is preferably highly cross-linked agarose.

Antibody purification

A process for the purification of antibodies

Separation method using single polymer phase systems

The present invention relates to a process of enriching one target compound from a liquid, which process comprises at least one step of isolation performed by differentially partitioning between two aqueous phases. In the present invention the phases are formed by adding a thermally responsive, self-associating (i.e. clouding) hydrophilic polymer, and if needed some additional salts, to an aqueous biotechnical solution (such as a fermentation sample or bioseparation process stream) under thermal and other conditions where the solution separates into a one polymer, two-phase system with one phase enriched in the polymer. The target compound is to be found in the phase not enriched in the polymer, while a significant though varying percentage of contaminants may differentially partition to the phase interface or the polymer enriched phase. With minor or no modification the target containing phase solution can be further processed via standard unit operations such as precipitation, chromatography, and filtration to further purify target and remove any residual polymer.

Mutated immunoglobulin-binding polypeptides

一种碱稳定性改进的Fc结合多肽，其包含由SEQ ID NO:1、SEQ ID NO:2、SEQ ID NO:3、SEQ ID NO:4、SEQ ID NO:5、SEQ ID NO:6、SEQ ID NO:7、SEQ ID NO:8、SEQ ID NO 26或SEQ ID NO 27限定的葡萄球菌A蛋白(SpA)的Fc结合结构域的突变体，其中至少对应于SEQ ID NO:4‑7中42位的位置处的丙氨酸残基突变成精氨酸和/或其中至少对应于SEQ ID NO:4‑7中37位的位置处的天冬氨酸残基突变成谷氨酸。

Method of preparing a separation matrix

Adsorption method and ligands

The invention relates to a method for removing a positively charged substanc e from an aqueous liquid (I) by contacting the liquid with a cation-exchanger (1), possibly followed by a subsequent desorption of said substance. The cation-exchanger is selected to be capable of (a) binding to said substance by cation-exchange in an aqueous liquid reference (II) at an ionic strength corresponding to 0.3 M NaCl and (b) permitting a break through capacity for said substance ~ 200 %, such as ~ 300 % or ~ 500 %, of the break-through capacity of said substance for a reference cation-exchanger (2) containing sulphopropyl groups -CH2CH2CH2SO2O-.The cation exchange ligands have an at least bimodal function by comprising a cation exchanging group and a separat e hydrogen-bonding atom. The invention also relates to a method for testing th e appropriateness of a cation-exchanger for removing a substance from a liquid and novel cation exchangers.

Chromatography Media

The present invention relates to a novel chromatography media, more closely a novel IMAC (Immobilized Metal Affinity Chromatography) media. The novel chromatography media comprises a pentaligand and provides high dynamic binding capacity as well as high purity of the sample proteins purified on the media of the invention.

Fc binding polypeptides

The present disclosure relates to a class of engineered polypeptides having a binding affinity for the Fc region of immunoglobulins while exhibiting a significantly reduced binding affinity to the VH3 region of immunoglobulins. The present disclosure also relates to methods for isolating an immunoglobulin using said polypeptides as well as to related products, such as separation matrices.

PROCESS FOR mRNA PURIFICATION

Method for forming polymer microparticles

Stabilization of fermented beverages

FC binding polypeptides

Method for isolating antibodies or antibody fragments lacking an Fc region capable of binding to protein A

本发明公开分离抗体或抗体片段的方法，其包含以下步骤：a）提供包含具有VH3区域且缺少能够结合至蛋白A的Fc区域的抗体或抗体片段的进料；b）将进料与具有共价偶联配体的分离树脂接触，其中配体包含如SEQ ID NO 1所定义的多肽且其中抗体或抗体片段结合至分离树脂；c）可选地用清洗液清洗分离树脂；d）用洗脱液从分离树脂中洗脱该抗体或抗体片段并回收该抗体或抗体片段。

Vh3 binding polypeptides

Adsorption method and ligands

Method of clarifying a crude protein solution

Chromatographic Methods for Purification of Proteins from Plasma

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.

Method and device for producing a coherent layer of even thickness of liquid or melt on a rotating disk

Method and device for continuously producing a coherent layer of a liquid/melt of even thickness by means of centrifugal action along the entire periphery of a rotating disk (13, 113), liquid/melt being supplied to the disk around its entire axis of rotation from means (12, 112) and leaving the disk as individual droplets. The means (12, 112) distributing the liquid/melt onto the disk (13, 113) has according to the invention essentially the same speed and direction of rotation as the disk, and the liquid/melt undergoes under the influence of centrifugal action circumferentially a spreading and change in velocity across the disk (13, 113) in contact with the same.

Separation matrix

Parallel assembly of chromatography column modules

A parallel assembly ( 2; 11; 51 ) of chromatography column modules ( 3 a,b,c; 13 a,b,c; 53 a,b,c, 90 a, b ) connected in a rigid housing ( 21; 61 ), the assembly having one common assembly inlet ( 15; 55 ) and one common assembly outlet ( 17; 57 ), each column module comprising a bed space ( 29 ) filled with chromatography medium and each column module comprises integrated fluid conduits which when the column module is connected with other column modules in the rigid housing are adapted to connect the bed space ( 29 ) of the column module with the assembly inlet ( 15; 55 ) and the assembly outlet ( 17; 57 ), wherein the total length and/or volume of the fluid conduit from the assembly inlet to one bed space together with the length and/or volume of the fluid conduit from the same bed space to the assembly outlet is substantially the same for all bed spaces and modules installed in the parallel assembly.

Production method for affinity chromatography resin

Chromatography medium for use in purification of enveloped virus particles or exosomes

An anion exchange chromatography medium (1) for use in purification of enveloped virus particles or exosomes from a feed, the anion exchange chromatography medium comprising a support material being functionalized with a ligand comprising a diamine functionality generating at least one weak anion exchange group to an ionic capacity of 10-500 µmol/mL.

A method for separating adeno-associated virus capsids, compositions obtained by said method and uses thereof

The present disclosure is directed to a method for separating adeno-associated virus capsids fully packaged with genetic material from adeno-associated virus capsids not fully packaged with genetic material, the method comprising the following steps: a) adding a liquid sample comprising adeno-associated virus capsids to a chromatography material, wherein the liquid sample comprises adeno-associated virus capsids of a purity of at least 90% and of a concentration of at least 1012 adeno-associated virus capsids/ml, of which at least 10% of the adeno-associated virus capsids are adeno-associated virus capsids fully packaged with genetic material, wherein the chromatography material comprises a strong, or partially strong, anion exchange chromatography material comprising a support and a ligand for binding to the adeno-associated virus capsids; wherein the chromatography material comprises a surface extender connecting the ligand to the support, wherein the surface extender is a polymer, wherein the polymer is selected from: (i) a polymer having a naturally occurring skeleton, such as a polysaccharide, such as starch, cellulose, dextran, or agarose; and (ii) a polymer having a synthetic skeleton, such as a polyvinyl alcohol, a polyacrylamide, a polymethacrylamide, or a polyvinyl ether; b) eluting the adeno-associated virus capsids fully packaged with genetic material from the chromatography material; wherein the adeno-associated virus capsids eluted in step (b) are eluted into eluate fractions, which eluate fractions combined comprise at least 50% of the adeno-associated virus capsids of the liquid sample added in step (a), of which at least 60% of the adeno-associated virus capsids are fully packaged with genetic material. Further disclosed are compositions, including pharmaceutical compositions, obtained by said separation method, as well as uses of such compositions, and uses of an anion chromatography material for separation of adeno-associated virus capsids.

Chromatography medium for use in purification of enveloped virus particles or exosomes

Sanitization method for affinity chromatography matrices

Separation Method

The invention relates to a method of isolating an immunoglobulin, comprising the steps of: a) providing a separation matrix comprising multimers of immunoglobulin-binding alkali-stabilized Protein A domains covalently coupled to a porous support: b) contacting a liquid sample comprising an immunoglobulin with the separation matrix; c) washing said separation matrix with a washing liquid; d) eluting the immunoglobulin from the separation matrix with an elution liquid, and e) cleaning the separation matrix with a cleaning liquid, wherein the alkali-stabilized Protein A domains comprise mutants of a parental Fc-binding domain of Staphylococcus Protein A (SpA).

A method for mixed mode adsorption and mixed mode adsorbents

Method for the removal of a substance from an aqueous liquid by ion exchange comprising providing a liquid with said substance is present; providing an adsorption matrix which comprises at least two different ligands; contacting the liquid with the matrix under a period of time and conditions sufficient to allow adsorption of the substance to the matrix; and adding an eluent that desorbs the substance from the matrix. Each one of the ligands interacts wit h the substance during the adsorption step, and at least one of the ligands is charged and capable of ionic interaction with the substance. The method can be run as a cation or anion exchange. The substance desorption can be performed by adding an eluent comprising an increasing ionic strength.The invention al so encompasses an adsorbent comprising at least two structurally different ligands, which interact with the same kind of substance when used in a separation procedure.

Method for purification of plasma proteins

The present invention relates to a method for purification of plasma proteins. More closely, the invention relates to a method using magnetic beads for separation of different plasma proteins from a plasma fraction, such as a cryoprecipitate or cryosupernatant of plasma, or alternatively directly from cell culture of recombinant plasma proteins.

Modified kappa light chain-binding polypeptides

Fc binding polypeptides

The present disclosure relates to a class of engineered polypeptides having a binding affinity for the Fc region of immunoglobulins while exhibiting a significantly reduced binding affinity to the VH3 region of immunoglobulins. The present disclosure also relates to methods for isolating an immunoglobulin using said polypeptides as well as to related products, such as separation matrices.

Fc binding polypeptides

The present disclosure relates to a class of engineered polypeptides having a binding affinity for the Fc region of immunoglobulins while exhibiting a significantly reduced binding affinity to the VH3 region of immunoglobulins. The present disclosure also relates to methods for isolating an immunoglobulin using said polypeptides as well as to related products, such as separation matrices.

Modified kappa light chain-binding polypeptides

Chromatography ligand and chromatography material, and uses thereof

A process and chromatography material for chromatography recovery of nucleic acid molecules

The present disclosure relates to a process for recovery of a nucleic acid product from a composition. The process (100) comprising: (i) contacting (110) the composition with a chromatography material functionalised with a ligand. The chromatography material comprises nanofibers; (ii) optionally washing (120) the functionalised chromatography material with a washing liquid phase; (iii) selectively eluting (130) said product by contacting the functionalised chromatography material with an elution liquid phase; (iv) cleaning-in-place (140) comprising regenerating the chromatography material by contacting with a cleaning liquid phase; (v) repeating steps (i)-(iii) for at least 15 cycles, wherein step (iv) is performed in at least one of said cycles; and (vi) collecting (150) recovered nucleic acid product. The chromatography material being capable of retaining a dynamic binding capacity at 10% breakthrough for said product after 50 cycles that is at least 80% of the corresponding dynamic binding capacity of the first cycle.

Alkali-stabilized kappa light chain-binding separation matrix

Periodic countercurrent chromatography separation of plasmids

Chromatography ligand comprising domain c from staphylococcus aureus protein a for antibody isolation

The present invention relates to a chromatography ligand, which comprises Domain C from Staphylococcus protein A (SpA), or a functional fragment or variant thereof. The chromatography ligand presents an advantageous capability of withstanding harsh cleaning in place (CIP) conditions, and is capable of binding Fab fragments of antibodies. The ligand may be provided with a terminal coupling group, such as arginine or cysteine, to facilitate its coupling to an insoluble carrier such as beads or a membrane. The invention also relates to a process of using the ligand in isolation of antibodies, and to a purification protocol which may include washing steps and/or regeneration with alkali.

改进的蛋白质纯化

本发明涉及蛋白质纯化，主要是在色谱领域中。更严格地说，本发明涉及使用包含C‑内含肽标签和N‑内含肽配体的断裂内含肽系统的亲和色谱法，其中N‑内含肽配体提供适合于大规模纯化任何重组目标蛋白质的增加的溶解度。

Método de producción para resina de cromatografía de afinidad

La presente invención se relaciona con el campo de la cromatografía y más específicamente con la producción de resinas de cromatografía de afinidad de proteínas que comprenden ligandos de afinidad basados en un fragmento N-terminal de una inteína dividida, tal como DnaE de Nostoc punctiforme, así como métodos para usar la misma. Los fragmentos N-terminales se producen en cuerpos de inclusión en las células bacterianas. (Traducción automática con Google Translate, sin valor legal)

Mål-bindende polypeptidmutant af et igg-bindende polypeptid omfattende et metalbindende motiv

Target-binding polypeptide mutant of an igg-binding polypeptide comprising a metal binding motif

Ligand and use thereof

The present invention is within the field of protein engineering and purification. The invention relates to a target-binding polypeptide mutant of an IgG binding polypeptide, such as Protein A, Protein G, Protein L or Protein M, comprising a metal binding motif. More closely the invention relates to an Fc binding ligand comprising an engineered protein based on the Protein A derived Z domain, to which a calcium binding EF-loop has been introduced.

Separation Matrix

The invention relates to an alkali-stable mutated Fc-binding Protein A domain, having at least 95% identity to SEQ ID NO: 8 or SEQ ED NO: 9.

Chromatography beads, production and use thereof

The present invention relates to chromatography beads, production and use thereof. More closely the invention relates to small, rigid and nan-permeable agarose beads suitable for example as stationary phase in high performance liquid chromatography (HPLC) for analyses of biomolecules, such as, peptides and proteins; and methods for producing such beads.

Chromatographic methods for purification of proteins from plasma

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.

A pre-screening method and a method for separating adeno-associated virus capsids

Chromatography columns, systems and methods

The present invention relates to axial flow chromatography columns, methods for separating one or more analytes in a liquid by the use of such columns, and systems employing such columns. The column comprises a first port and a second port, the first port and said second port being at essentially the same level or elevation above the level of the bed space on the chromatography column.

Method of Cleaning and/or Sanitizing a Separation Matrix

The present invention concerns a method of cleaning and/or sanitizing a separation matrix comprising multimers of immunoglobulin-binding alkali-stabilized Protein A domains covalently coupled to a porous support. The method comprises the steps of: a) optionally purifying a mixture comprising a first immunoglobulin using the separation matrix; b) providing a cleaning liquid comprising at least 50% by volume of an aqueous alkali metal hydroxide solution; and c) cleaning and/or sanitizing the separation matrix by contacting the cleaning liquid with the separation matrix for a predetermined contact time. The alkali-stabilized Protein A domains comprise mutants of a parental Fc-binding domain of Staphylococcus Protein A (SpA), as defined by SEQ ID NO 51 or SEQ ID NO 52, wherein the amino acid residues at positions 13 and 44 of SEQ ID NO 51 or 52 are asparagines and wherein at least the asparagine residue at position 3 of SEQ ID NO 51 or 52 has been mutated to an amino acid selected from the group consisting of glutamic acid, lysine, tyrosine, threonine, phenylalanine, leucine, isoleucine, tryptophan, methionine, valine, alanine, histidine and arginine.

Improved protein purification

The present invention relates to protein purification, primarily in the chromatographic field. More closely, the invention relates to affinity chromatography using a split intein system comprising a C-intein tag and N-intein ligand, wherein the N-intein ligand provides increased solubility suitable for large scale purification of any recombinant target protein.

生物过程系统中的方法

本发明涉及一种用于估计生物过程材料当在生物过程系统中使用时的性能的方法。该生物过程材料包括各自具有数据性质的至少两个成分。该方法包括：i)得到(81)用来产生生物过程材料的至少两个成分的数据性质；ii)定义(82)用来处理至少两个成分的规程；iii)按照所定义的过程参数来处理(83)至少两个成分，以得到至少一个产品；iv)测量(84)每个产品的数据性质；v)基于每个产品的所测量的数据性质和/或来自至少两个成分的数据性质来计算(85)每个产品的数据性质；以及vi)如果产品是生物过程材料，则处理(88)所测量的数据性质和所计算的数据性质，以估计生物过程材料对生物过程系统中的目标产品的影响；或者(vii)如果产品不是生物过程材料，则将该产品看作是中间材料，并且在每个产品作为至少两个成分中的一个成分的情况下重复进行(87)步骤iii)‑vi)。

Method in bioprocess system

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. The method comprises:i) obtaining (81) the data properties for the at least two ingredients used to produce the bioprocess material; ii) defining (82) procedures to process the at least two ingredients; iii) processing (83) the at least two ingredients according to the defined process parameters to obtain at least a product; iv)measuring (84) data properties of each product, v) calculating (85) data properties of each product based on the measured data properties of each product and/or data properties from the at least two ingredients, and vi)if the product is the bioprocess material, processing (88) the measured and calculated data properties to estimate the impact of the bioprocess material on a target product in the bioprocess system, or vii) if the product is not the bioprocess material, treating the product as an intermediate material and repeating (87) steps iii)-vi) with each product as one of the at least two ingredients.

分离双特异性抗体的方法

本发明涉及分离双特异性抗体或双特异性抗体片段的方法。该方法包括以下步骤：a)提供包含双特异性抗体或双特异性抗体片段的进料；b)使所述进料与具有与载体偶联的亲和配体的分离基质接触；c)任选地用洗涤液洗涤分离树脂；d)将洗脱缓冲液施加到分离树脂，以洗脱与亲和配体结合的抗体或抗体片段；其中在步骤d)中，对洗脱缓冲液施加pH梯度，所述pH梯度为从约6至约2。

Modificerede kappa-letkæde-bindende polypeptider

Separation matrix and method of separation

The invention discloses a separation matrix comprising polysaccharide gel beads, wherein said polysaccharide gel beads comprise embedded fibers. The invention further discloses a method of preparing the separation matrix and use of the matrix for separation purposes.

Mutated immunoglobulin-binding polypeptides

An Fc-binding polypeptide of improved alkali stability, comprising a mutant of an Fc-binding domain of Staphylococcus Protein A (SpA), as defined by SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO:3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:22, SEQ ID NO 51 or SEQ ID NO 52 wherein at least the asparagine or serine residue at the position corresponding to position 11 in SEQ ID NO:4-7 has been mutated to an amino acid selected from the group consisting of glutamic acid, lysine, tyrosine, threonine, phenylalanine, leucine, isoleucine, tryptophan, methionine, valine, alanine, histidine and arginine.

A method for preparation of a separation matrix

A method for preparation of a separation matrix, comprising the steps of: a) providing a solid support and an alkali-stable ligand derived from an immunoglobulin- binding bacterial protein; b) reacting said alkali-stable ligand with said solid support to form a separation matrix having covalently coupled alkali-stable ligands; and c) washing said separation matrix having covalently coupled alkali-stable ligands with a wash solution comprising at least 10 mM of an alkali metal hydroxide.

Un método para la preparación de una matriz de separación

Un método para la preparación de una matriz de separación, que comprende los pasos de: a) proporcionar un soporte sólido y un ligando estable a los álcalis derivado de una proteína bacteriana de unión a inmunoglobulina; b) hacer reaccionar dicho ligando estable a los álcalis con dicho soporte sólido para formar una matriz de separación que tiene ligandos estables a los álcalis acoplados covalentemente; yc) lavar dicha matriz de separación que tiene ligandos estables a los álcalis acoplados covalentemente con una solución de lavado que comprende al menos 10 mM de un hidróxido de metal alcalino. (Traducción automática con Google Translate, sin valor legal)

A method for preparation of a separation matrix

Method for preparation of a separation matrix

Methods that include providing and reacting a solid support and an alkali-stable ligand derived from an immunoglobulin-binding bacterial protein to form a separation matrix having covalently coupled alkali-stable ligands; and washing with a wash solution comprising at least 10 mM of an alkali metal hydroxide.

A pre-screening method and a method for separating adeno-associated virus capsids

The present disclosure is directed to a method for determining elution conditions suitable for separating adeno-associated virus (AAV) capsids fully packaged with genetic material from AAV capsids not fully packaged with genetic material, the method comprising: (a) adding a liquid sample comprising AAV capsids to a strong, or partially strong, anion exchange chromatography material comprising a surface extender, (b) eluting the AAV virus capsids from the chromatography material by applying an elution buffer comprising a step gradient of increasing conductivity, which increases by from about 0.5 to about 3 mS/cm per step, (c) based on an elution profile obtained in step (b), determining a first value of conductivity or conductivity-related parameter, which is suitable for eluting the adeno-associated virus capsids not fully packaged with genetic material, and (d) based on the elution profile obtained in step (b), determining a second value of conductivity or conductivity-related parameter, which is suitable for eluting the adeno-associated virus capsids fully packaged with genetic material. Further disclosed are methods for separating fully packaged AAV capsids from not fully packaged AAV capsids based on pre-determined first and second value of conductivity or conductivity-related parameter, as well as use of an anion exchange chromatography material for separating fully packaged AAV capsids from not fully packaged AAV capsids.

Parallel assembly of chromatography column modules

A parallel assembly of chromatography column modules, the assembly having one common assembly inlet and one common assembly outlet, each column module comprising a bed space filled with chromatography medium and each column module comprises integrated fluid conduits which when the column module is connected with other column modules are adapted to connect the bed space of the column module with the assembly inlet and the assembly outlet, wherein the total length and/or volume of the fluid conduit from the assembly inlet to one bed space together with the length and/or volume of the fluid conduit from the same bed space to the assembly outlet is substantially the same for all bed spaces and modules installed in the parallel assembly.

A chromatography device, system, and use thereof for analytic separation

Modificerede kappa-letkæde-bindende polypeptider

A method for separating adeno-associated virus capsids, compositions obtained by said method and uses thereof

The present disclosure is directed to a method for separating adeno-associated virus capsids fully packaged with genetic material from adeno-associated virus capsids not fully packaged with genetic material, the method comprising the following steps: a) adding a liquid sample comprising adeno-associated virus capsids to a chromatography material, wherein the liquid sample comprises adeno-associated virus capsids of a purity of at least 90% and of a concentration of at least 1012 adeno-associated virus capsids/ml, of which at least 10% of the adeno-associated virus capsids are adeno-associated virus capsids fully packaged with genetic material, wherein the chromatography material comprises a strong, or partially strong, anion exchange chromatography material comprising a support and a ligand for binding to the adeno-associated virus capsids; wherein the chromatography material comprises a surface extender connecting the ligand to the support, wherein the surface extender is a polymer, wherein the polymer is selected from: (i) a polymer having a naturally occurring skeleton, such as a polysaccharide, such as starch, cellulose, dextran, or agarose; and (ii) a polymer having a synthetic skeleton, such as a polyvinyl alcohol, a polyacrylamide, a polymethacrylamide, or a polyvinyl ether; b) eluting the adeno-associated virus capsids fully packaged with genetic material from the chromatography material; wherein the adeno-associated virus capsids eluted in step (b) are eluted into eluate fractions, which eluate fractions combined comprise at least 50% of the adeno-associated virus capsids of the liquid sample added in step (a), of which at least 60% of the adeno-associated virus capsids are fully packaged with genetic material. Further disclosed are compositions, including pharmaceutical compositions, obtained by said separation method, as well as uses of such compositions, and uses of an anion chromatography material for separation of adeno-associated virus capsids.

包括内部支柱的色谱柱

本发明公开一种生物过程色谱柱，其包括：a)床室，该床室由至少一个侧壁、第一床支承筛和第二床支承筛界定；b)第一端壁，该第一端壁固定到侧壁或与侧壁整体结合，其中第一端口经由第一分配器流体地连接到第一床支承筛；c)第二端壁，该第二端壁固定到侧壁或与侧壁整体结合，其中第二端口经由第二分配器流体地连接到第二床支承筛；d)壁中的填充端口；以及e)内部支柱，该内部支柱固定到端壁中的至少一个或与端壁中的至少一个整体结合，且延伸到床室中。

Method for virus capture

The present invention relates to a method for virus capture or separation. More closely, the invention relates to a method for direct influenza and adenovirus capture using magnetic beads. The method allows direct separation from crude cell lysate in a rapid manner.

Vh3 binding polypeptides

The present disclosure relates to a class of engineered polypeptides having a binding affinity for the VH3 region of immunoglobulins and exhibiting desirable alkali clean stability properties. Additionally, the polypeptides exhibit significantly reduced binding affinity for the Fc region of immunoglobulins. The present disclosure also relates to methods for isolating an immunoglobulin or fragment thereof using said polypeptides as well as to related products.

Improved protein purification

The present invention relates to protein purification, primarily in the chromatographic field. More closely, the invention relates to affinity chromatography using a split intein system comprising a C-intein tag and N-intein ligand, wherein the N-intein ligand provides increased solubility suitable for large scale purification of any recombinant target protein.

分离腺相关病毒衣壳的方法、通过该方法获得的组合物及其用途

本公开涉及一种用于将完整包装遗传物质的腺相关病毒衣壳与不完整包装遗传物质的腺相关病毒衣壳分离的方法，所述方法包括以下步骤：a)将包含腺相关病毒衣壳的液体样品添加到色谱材料，其中所述液体样品包含纯度为至少90％并且浓度为至少10 12 个腺相关病毒衣壳/ml的腺相关病毒衣壳，其中至少10％的腺相关病毒衣壳为完整包装遗传物质的腺相关病毒衣壳，其中所述色谱材料包含强或部分强的阴离子交换色谱材料，所述阴离子交换色谱材料包含载体和用于与腺相关病毒衣壳结合的配体；其中所述色谱材料包含将配体连接至载体的表面延伸剂，其中所述表面延伸剂为聚合物，其中所述聚合物选自：(i)具有天然存在的骨架的聚合物，如多糖，如淀粉、纤维素、葡聚糖或琼脂糖；和(ii)具有合成骨架的聚合物，如聚乙烯醇、聚丙烯酰胺、聚甲基丙烯酰胺或聚乙烯基醚；b)从色谱材料洗脱完整包装遗传物质的腺相关病毒衣壳；其中将步骤(b)中洗脱的腺相关病毒衣壳洗脱成洗脱物级分，合并的洗脱物级分包含步骤(a)中添加的液体样品的腺相关病毒衣壳的至少50％，其中至少60％的腺相关病毒衣壳完整包装遗传物质。还公开了通过所述分离方法获得的组合物，包括药物组合物，以及这样的组合物的用途，和阴离子色谱材料用于分离腺相关病毒衣壳的用途。

Separation Matrix and a Method of Separating Antibodies

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 μm.

Separation Matrix

The invention relates to a separation matrix comprising at least 11 mg/ml Fc-binding ligands covalently coupled to a porous support, wherein: a) the ligands comprise multimers of alkali-stabilized Protein A domains, and b) the porous support comprises cross-linked polymer particles having a volume-weighted median diameter (d50,v) of 56-70 micrometers and a dry solids weight of 55-80 mg/ml.

用于亲和色谱基质的消毒方法

本发明公开了一种用于亲和色谱基质清洗或消毒的方法，包括以下步骤：a）提供一种具有偶联到载体的耐氧化蛋白质类配体的亲和色谱基质，b）使所述基质与含有至少一种由分子式I定义的氧化剂的消毒溶液接触，R–O–O–H(I)，其中，R为氢或酰基R’‑C(O)‑，R’为氢或甲基、乙基或丙基。

用于亲和色谱基质的消毒方法

本发明公开了一种用于亲和色谱基质清洗或消毒的方法，包括以下步骤：a）提供一种具有偶联到载体的耐氧化蛋白质类配体的亲和色谱基质，b）使所述基质与含有至少一种由分子式I定义的氧化剂的消毒溶液接触，R–O–O–H(I)，其中，R为氢或酰基R’‑C(O)‑，R’为氢或甲基、乙基或丙基。

Método de desinfección para matrices de cromatografía por afinidad

La invención divulga un método para limpiar o higienizar una matriz de cromatografía de afinidad, que comprende los pasos de: a) proporcionar una matriz de cromatografía de afinidad que tiene ligandos proteicos tolerantes a la oxidación acoplados a un soporte, b) poner en contacto la matriz con una solución de higienización que comprende al menos un oxidante definido por la fórmula I, R -O -O -H (I) en la que R es hidrógeno o un grupo acilo R'-C(O)-, siendo R' un hidrógeno o un grupo metilo, etilo o propilo. (Traducción automática con Google Translate, sin valor legal)

Desinfektionsfremgangsmåde til affinitetskromatografimatricer

分离缺少能够结合至蛋白A的Fc区域的抗体或抗体片段的方法

本发明公开分离抗体或抗体片段的方法，其包含以下步骤：a）提供包含具有VH3区域且缺少能够结合至蛋白A的Fc区域的抗体或抗体片段的进料；b）将进料与具有共价偶联配体的分离树脂接触，其中配体包含如SEQ ID NO 1所定义的多肽且其中抗体或抗体片段结合至分离树脂；c）可选地用清洗液清洗分离树脂；d）用洗脱液从分离树脂中洗脱该抗体或抗体片段并回收该抗体或抗体片段。

Separation matrix

The invention relates to an alkali-stable mutated Fc-binding Protein A domain, having at least 95% identity to SEQ ID NO: 8 or SEQ ID NO: 9.

具有入口阀和出口阀的可层叠的色谱柱模块

本发明公开了一种具有入口阀和出口阀的可层叠的色谱柱模块，该色谱柱模块可与相似的色谱模块层叠，其包括柱室(2)，所述柱室(2)流体地连接至柱入口(3)和柱出口(4)，其中柱入口和出口均包括阀(5)，所述阀布置成在柱入口或出口与下者连接时从闭合位置移动至打开位置：a)相似的色谱模块的柱出口或入口或者b)流体板的出口或入口。本发明进一步公开了一种色谱柱模块的层叠以及所述层叠用于生物分子的分离的用途。

用于病毒捕获的方法

本发明涉及一种用于病毒捕获或分离的方法。更严密地说，本发明涉及一种使用磁珠直接捕获流感和腺病毒的方法。该方法允许以快速的方式从粗细胞裂解物中直接分离。

Alkali-stabilized kappa light chain-binding separation matrix

The present invention relates to a separation matrix for affinity chromatography and separation of biomolecules based on the presence of a kappa light chain. More specifically, the present invention relates to a separation matrix comprising at least 12 mg/ml kappa light chain-binding ligands covalently coupled to a porous support, wherein said kappa light chain-binding ligands comprise, consists essentially of, or consists of multimers of alkali-stabilized Finegoldia magna (formerly Peptostreptococcus Magnus) Protein L domains; and wherein said porous support comprises polymer particles having a Dry solids weight (D W ) of 50-200 mg/ml, a volume-weighted median diameter (D50v) of 30-100 μm. The invention also relates to methods of using said separation matrix.

A method of separating bispecific antibodies

The present invention relates to a method of separating bispecific antibodies or bispecific antibody fragments. The method comprises the steps of a) providing a feed comprising bispecific antibodies or bispecific antibody fragments; b) contacting the feed with a separation matrix having affinity ligands coupled to a support; c) optionally washing the separation resin with a washing liquid; d) applying an elution buffer to the separation resin, to elute the antibodies or antibody fragments bound to the affinity ligand; wherein in step d) a pH gradient is applied over the elution buffer, said pH gradient being from about 6 to about 2.

A chromatography device, system, and use thereof for analytic separation

The present disclosure is directed to a chromatography device for use in an analytic separation method, comprising a chromatography material, which comprises a support and a ligand, wherein the ligand of the chromatography material is defined by the following Formula (I) wherein R1 is selected from C1-C3 alkyl, and R2 and R3 are independently selected from C1-C3 alkyl, CH2OH, and CH2CHOHCH3, wherein the volume of the chromatography material is from about 0.1 mL to about 2 mL. Further disclosed are uses of said chromatography device and a method for separating adeno-associated virus capsids fully packaged with genetic material from adeno- associated virus capsids not fully packaged with genetic material, as well as a kit of parts and a chromatography system for use in analytic separation of adeno-associated capsids.

Separación de plásmidos por cromatografía en contracorriente periódica

Un método de separación continua de un plásmido de una alimentación de proceso en un aparato con al menos tres columnas de cromatografía empaquetadas con partículas de matriz de separación, en el que mientras una columna de cromatografía se carga con la alimentación de proceso, otra columna de cromatografía se eluye con un eluyente para recuperar el Se separa el plásmido y se eluye otra columna de cromatografía con otro eluyente para eliminar los contaminantes. (Traducción automática con Google Translate, sin valor legal)

Separation matrix

The invention relates to an alkali-stable mutated Fc-binding Protein A domain, having at least 95% identity to SEQ ID NO: 8 or SEQ ID NO: 9.

Purification of poly a-tagged products

The invention relates to processes for purification of poly-tagged products, such as mRNA, from synthetic or biological compositions. The process involves contacting the composition with a oligo d (T)-functionalized chromatography medium comprising a convection-based chromatography material.

聚a标记的产品的纯化

本发明涉及从合成或生物组合物纯化多标记产品，例如mRNA的方法。所述方法包括将组合物与寡d(T)‑官能化色谱介质接触，所述色谱介质包含基于对流的色谱材料。

Purification of poly a-tagged products

The invention relates to processes for purification of poly-tagged products, such as mRNA, from synthetic or biological compositions. The process involves contacting the composition with a oligo d (T)-functionalized chromatography medium comprising a convection-based chromatography material.

Purification of poly a-tagged products

The invention relates to processes for purification of poly-tagged products, such as mRNA, from synthetic or biological compositions. The process involves contacting the composition with a oligo d (T)-functionalized chromatography medium comprising a convection-based chromatography material.

Chromatography ligand and chromatography material, and uses thereof

The present disclosure provides a chromatography ligand defined by Formula I: wherein: X 1 is selected from CO and SO 2 ; each of R 1 -R 5 is independently selected from H, F, Cl, O, N, S, C 1-3 alkyl, and C 1- 3 alkyl-X 2 ; any two adjacent moieties selected from R 1 -R 5 together with the atoms to which they are attached may form a 5- or 6-membered heterocyclic or carbocyclic ring; and X 2 is selected from O, S, NH(CO), (CO)NH, NH(SO 2 ), and (SO 2 )NH; and provided that: i. when each of R 1 -R 5 is H, X 1 is SO 2 ; ii. when any two adjacent moieties selected from R 1 -R 5 together with the atoms to which they are attached form a 5-membered heterocyclic containing ring containing two oxygen atoms in the ring, X 1 is SO 2 ; and iii. when three of R 1 -R 5 are CH 3 O, X 1 is CO. The present disclosure also relates to a chromatography material comprising a support and the herein disclosed chromatography ligand coupled to the support. Further disclosed is a use of said chromatography material for separating one or more target molecules from impurities, as well as a method for separating one or more target molecules from impurities.

Purification of poly a-tagged products

The invention relates to a chromatography medium comprising a convection-based chromatography material functionalized with oligo d(T)-ligands, wherein the material comprises polymer nanofibers and is in the form of one or more membrane(s) or sheet(s), wherein the oligo(dT)-ligand is a (d)T_10-50 ligand. The invention also relates to processes for purification of polyA-tagged products, such as mRNA, from a synthetic or biological composition, with the use of the chromatography material.

Chromatography matrix

The invention discloses a separation matrix for purification of biomacromolecules, comprising a plurality of particles (1) having a core region (2) and a shell region (3), wherein: a) said shell region is accessible to a target biomacromolecule; b) said core region is less accessible to the target biomacromolecule than the shell region; and c) the core region comprises a grafted polymer comprising residues of at least one polymerizable monomer.

A method for separating adeno-associated virus capsids, compositions obtained by said method and uses thereof

Protein purification using a split intein system

The present invention relates to protein purification, primarily in the chromatographic field. More closely, the invention relates to affinity chromatography using a split intein system with an improved C-intein tag and N-intein ligand, wherein the target protein may be purified as a tag-less end product with a native N-terminus.