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1. 发明专利

JP2014077000A Antibody purification 有权
标题翻译：抗体纯化
公开(公告)号：JP2014077000A
公开(公告)日：2014-05-01
申请号：JP2013252725
申请日：2013-12-06
申请人： Abbvie Biotechnology Ltd , アッヴィバイオテクノロジーリミテッド
发明人： WAN MIN W , AVGERINOS GEORGE , ZARBIS-PAPASTOITSIS GREGORY
IPC分类号： C07K1/18 , A61K39/395 , A61P1/00 , A61P19/02 , A61P25/00 , A61P27/02 , A61P29/00 , A61P37/06 , A61P37/08
CPC分类号： A61K39/39591 , A61K31/519 , A61K39/3955 , A61K47/22 , A61K47/26 , A61K2039/505 , A61K2039/54 , A61K2039/545 , C07K1/18 , C07K1/36 , C07K16/065 , C07K16/241 , C07K2317/14 , C07K2317/21 , C07K2317/94
摘要： PROBLEM TO BE SOLVED: To provide an improved method to obtain an antibody preparation containing a decreased amount of host cell proteins including procathepsin L.SOLUTION: A method of purifying antibodies expressed in a host cell expression system in which the obtained antibody preparation comprises a decreased amount of host cell proteins(HCP) including procathepsin L, is developed. Development of a reproducible method of accurately detecting HCP and a kinetic assay is also included. A method for producing an antibody preparation with decreased HCP from a mixture of antibody and at least one HCP, comprises an ion-exchange separation step, and applying the mixture to a first ion-exchange material so that an antibody preparation with decreased HCP is obtained. A method of preparing antibodies comprises (a) applying the mixture to first ion-exchange resin in an equilibrated buffer solution, (b) washing HCP from resin in a plurality of washing steps, and (c) eluting antibodies from the resin with an elution buffer solution to prepare a first elution solution.
摘要翻译：要解决的问题：提供一种改进的方法，以获得含有宿主细胞蛋白质含量降低的抗体制剂，包括组氨酸蛋白酶L。解决方案：一种在宿主细胞表达系统中表达的纯化抗体的方法，其中所获得的抗体制剂包含减少的开发了含有组氨酸蛋白酶L的宿主细胞蛋白（HCP）的量。还包括开发精确检测HCP和动力学测定的可重现方法。从抗体和至少一种HCP的混合物制备具有降低的HCP的抗体制剂的方法包括离子交换分离步骤，并将该混合物施加到第一离子交换材料上，从而获得具有降低的HCP的抗体制剂。制备抗体的方法包括（a）将所述混合物施加到平衡的缓冲溶液中的第一离子交换树脂中，（b）在多个洗涤步骤中从树脂中洗涤HCP，和（c）以洗脱的方式从所述树脂洗脱抗体缓冲溶液以制备第一洗脱溶液。

2. 发明专利

NZ611859A Antibody purification 未知
公开(公告)号：NZ611859A
公开(公告)日：2014-12-24
申请号：NZ61185907
申请日：2007-04-04
申请人： ABBVIE BIOTECHNOLOGY LTD
发明人： WAN MIN W , ZARBIS-PAPASTOITSIS GREGORY , AVGERINOS GEORGE
IPC分类号： C07K1/18 , A61K39/395 , C07K1/20 , C07K1/36 , C07K16/00 , C07K16/24
摘要： Disclosed is a liquid composition comprising an isolated human anti-TNFα antibody, or an antigen-binding portion thereof, wherein the composition has no detectable cathepsin L activity as determined by a cathepsin L kinetic assay; wherein the anti-TNFα antibody or antigen-binding portion comprises: 1. A light chain variable region comprising: - a light chain CDR3 comprising the amino acid sequence of QRYNRAPYX or an amino acid sequence differing from QRYNRAPYX by a single alanine substitution at position 1, 4, 5, 7 or 8; - a light chain CDR2 comprising the amino acid sequence of AASTLQS; and - a light chain CDR1 comprising the amino acid sequence of RASQGIRNYLA; and 2. A heavy chain variable region comprising: - a heavy chain CDR3 comprising the amino acid sequence of VSYLSTASSLDX or an amino acid sequence differing from VSYLSTASSLDX by a single alanine substitution at position 2, 3, 4, 5, 6, 8, 9, 10 or 11; - a heavy chain CDR2 comprising the amino acid sequence of AITWNSGHIDYADSVEG; and - a heavy chain CDR1 comprising the amino acid sequence of DYAMH.

3. 发明专利

AU2018201769A1 Antibody purification 未知
公开(公告)号：AU2018201769A1
公开(公告)日：2018-04-05
申请号：AU2018201769
申请日：2018-03-13
申请人： ABBVIE BIOTECHNOLOGY LTD
发明人： AVGERINOS GEORGE , WAN MIN W , ZARBIS-PAPASTOITSIS GREGORY
IPC分类号： C07K1/18 , A61K39/395 , C07K1/20 , C07K1/36 , C07K16/00 , C07K16/24
摘要： ANTIBODY PURIFICATION The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

4. 发明专利

NZ610566A Antibody purification 未知
公开(公告)号：NZ610566A
公开(公告)日：2014-09-26
申请号：NZ61056607
申请日：2007-04-04
申请人： ABBVIE BIOTECHNOLOGY LTD
发明人： WAN MIN W , ZARBIS-PAPASTOITSIS GREGORY , AVGERINOS GEORGE
IPC分类号： C07K1/18 , A61K39/395 , C07K1/20 , C07K1/36 , C07K16/00 , C07K16/24
摘要： Disclosed is a pharmaceutical composition comprising an isolated human anti-TNFalpha antibody, or an antigen-binding portion thereof, and a pharmaceutically acceptable carrier, wherein the anti-TNFalpha antibody, or antigen-binding portion thereof, comprises a light chain variable region comprising a light chain CDR3 comprising the amino acid sequence of SEQ ID NO: 3 or an amino acid sequence differing from SEQ ID NO: 3 by a single alanine substitution at position 1, 4, 5, 7 or 8, a light chain CDR 2 comprising the amino acid sequence of SEQ ID NO: 5, and a light chain CDR1 comprising the amino acid sequence of SEQ ID NO: 7; and a heavy chain variable region comprising a heavy chain CDR3 comprising the amino acid sequence of SEQ ID NO: 4 or an amino acid sequence differing from SEQ ID NO: 4 by a single alanine substitution at position 2, 3, 4, 5, 6, 8, 9, 10 or 11, a heavy chain CDR2 comprising the amino acid sequence of SEQ ID NO: 6, and a heavy chain CDR1 comprising the amino acid sequence of SEQ ID NO: 8, wherein the composition is characterised in that when the composition is assayed in a cathepsin L kinetic assay, a level of cathepsin L activity less than 1.84 RFU/s/mg of antibody is observed, and wherein the cathepsin L kinetic assay comprises: i) diluting the composition in a polystyrene container in a solution containing 25 mM NaOAc, 5 mM DTT and 1 mM EDTA at pH 5.5, ii) adding dextran sulfate to a concentration of 0.035 μg/mL and incubating at 37 degrees Celsius for six hours, iii) adding Z-leucine-arginine covalently bound at its C-terminus to a fluorescent 7-amino-4-methyl coumarin (Z-leucine-arginine-AMC), wherein the diluting, adding, and incubating steps are sufficient to permit the measurement of cathepsin L hydrolysis of the Z-leucine-arginine-AMC within a linear range, and iv) measuring Z-leucine-arginine-AMC hydrolysis in the linear range in RFU/s/mg of antibody, wherein the sequences are as defined in the complete specification.

5. 发明专利

ZA201100565B ANTIBODY PURIFICATION 未知
公开(公告)号：ZA201100565B
公开(公告)日：2014-09-25
申请号：ZA201100565
申请日：2011-01-21
申请人： ABBVIE BIOTECHNOLOGY LTD
发明人： WAN MIN W , AVGERINOS GEORGE , ZARBIS-PAPASTOITSIS GREGORY
IPC分类号： C07K20060101

6. 发明专利

ZA200808372B ANTIBODY PURIFICATION 未知
公开(公告)号：ZA200808372B
公开(公告)日：2011-11-30
申请号：ZA200808372
申请日：2008-10-01
申请人： ABBVIE BIOTECHNOLOGY LTD
发明人： WAN MIN W , AVGERINOS GEORGE , ZARBIS PAPASTOITSIS GREGORY
IPC分类号： C07K20060101
摘要： The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

7. 发明专利

CA2911000A1 ANTIBODY PURIFICATION 未知
公开(公告)号：CA2911000A1
公开(公告)日：2007-10-18
申请号：CA2911000
申请日：2007-04-04
申请人： ABBVIE BIOTECHNOLOGY LTD
发明人： WAN MIN W , AVGERINOS GEORGE , ZARBIS-PAPASTOITSIS GREGORY
IPC分类号： A61K39/395 , A61P1/00 , A61P17/06 , A61P19/02 , A61P37/06 , C07K16/24 , C12P21/08
摘要： The invention provides a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, comprising an ion exchange separation step wherein the mixture is subjected to a first ion exchange material, such that the HCP-reduced antibody preparation is obtained.

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