公开(公告)号：US20180179545A1

公开(公告)日：2018-06-28

申请号：US15897290

申请日：2018-02-15

Applicant: Kelvin LEE ,  Abraham Lenhoff ,  Kristin Valente ,  Nick Levy ,  Yatin Gokarn

Inventor： Kelvin LEE ,  Abraham Lenhoff ,  Kristin Valente ,  Nick Levy ,  Yatin Gokarn

IPC: C12N15/113 ,  C07K16/00 ,  A61K38/17 ,  A61K38/39 ,  A61K38/42 ,  A61K38/44 ,  A61K38/45 ,  A61K38/48 ,  A61K38/52 ,  A61K47/26 ,  C12P21/00 ,  C12N9/20 ,  C12P21/02

CPC classification number: C12N15/1137 ,  A61K38/1709 ,  A61K38/1741 ,  A61K38/1761 ,  A61K38/1774 ,  A61K38/39 ,  A61K38/42 ,  A61K38/44 ,  A61K38/443 ,  A61K38/45 ,  A61K38/4813 ,  A61K38/482 ,  A61K38/488 ,  A61K38/52 ,  A61K47/26 ,  C07K16/00 ,  C12N9/20 ,  C12N2310/10 ,  C12N2310/14 ,  C12N2310/20 ,  C12P21/005 ,  C12P21/02 ,  C12Y104/03013 ,  C12Y111/01015 ,  C12Y205/01018 ,  C12Y207/04006 ,  C12Y207/11001 ,  C12Y301/01034 ,  C12Y304/16005 ,  C12Y304/21 ,  C12Y304/23005 ,  C12Y502/01008 ,  C12Y503/04001

Abstract: The invention relates a method for producing a stable recombinant protein, comprising growing a non-naturally occurring host cell in a culture medium to produce a recombinant protein, and making a composition comprising the recombinant protein and a polysorbate. The production of endogenous lipoprotein lipase by the host cell is reduced. The endogenous lipoprotein lipase is present in the composition in a small amount, and is capable of degrading the polysorbate. The invention also relates to the relevant host cells and compositions, and preparation thereof.

公开(公告)号：US20190390203A1

公开(公告)日：2019-12-26

申请号：US16565606

申请日：2019-09-10

Applicant: Kelvin LEE ,  Abraham Lenhoff ,  Kristin Valente ,  Nick Levy ,  Yatin Gokarn

Inventor： Kelvin LEE ,  Abraham Lenhoff ,  Kristin Valente ,  Nick Levy ,  Yatin Gokarn

IPC: C12N15/113 ,  C12P21/00 ,  A61K47/26 ,  A61K38/52 ,  A61K38/48 ,  A61K38/45 ,  A61K38/44 ,  A61K38/42 ,  A61K38/39 ,  A61K38/17 ,  C12N9/20 ,  C12P21/02 ,  C07K16/00

Abstract: The invention relates a method for producing a stable recombinant protein, comprising growing a non-naturally occurring host cell in a culture medium to produce a recombinant protein, and making a composition comprising the recombinant protein and a polysorbate. The production of endogenous lipoprotein lipase by the host cell is reduced. The endogenous lipoprotein lipase is present in the composition in a small amount, and is capable of degrading the polysorbate. The invention also relates to the relevant host cells and compositions, and preparation thereof.

公开(公告)号：US09932591B2

公开(公告)日：2018-04-03

申请号：US15105925

申请日：2014-12-18

Applicant: Kelvin Lee ,  Abraham Lenhoff ,  Kristin Valente ,  Nick Levy ,  Yatin Gokarn

Inventor： Kelvin Lee ,  Abraham Lenhoff ,  Kristin Valente ,  Nick Levy ,  Yatin Gokarn

IPC: C12N15/11 ,  C12N15/113 ,  C07K16/00 ,  C12P21/02 ,  C12N9/20 ,  A61K38/17 ,  A61K38/39 ,  A61K38/42 ,  A61K38/44 ,  A61K38/45 ,  A61K38/48 ,  A61K38/52 ,  A61K47/26 ,  C12P21/00

CPC classification number: C12N15/1137 ,  A61K38/1709 ,  A61K38/1741 ,  A61K38/1761 ,  A61K38/1774 ,  A61K38/39 ,  A61K38/42 ,  A61K38/44 ,  A61K38/443 ,  A61K38/45 ,  A61K38/4813 ,  A61K38/482 ,  A61K38/488 ,  A61K38/52 ,  A61K47/26 ,  C07K16/00 ,  C12N9/20 ,  C12N2310/10 ,  C12N2310/14 ,  C12N2310/20 ,  C12P21/005 ,  C12P21/02 ,  C12Y104/03013 ,  C12Y111/01015 ,  C12Y205/01018 ,  C12Y207/04006 ,  C12Y207/11001 ,  C12Y301/01034 ,  C12Y304/16005 ,  C12Y304/21 ,  C12Y304/23005 ,  C12Y502/01008 ,  C12Y503/04001

Abstract: The invention relates a method for producing a stable recombinant protein, comprising growing a non-naturally occurring host cell in a culture medium to produce a recombinant protein, and making a composition comprising the recombinant protein and a polysorbate. The production of endogenous lipoprotein lipase by the host cell is reduced. The endogenous lipoprotein lipase is present in the composition in a small amount, and is capable of degrading the polysorbate. The invention also relates to the relevant host cells and compositions, and preparation thereof.

公开(公告)号：US20160312226A1

公开(公告)日：2016-10-27

申请号：US15105925

申请日：2014-12-18

Applicant: Kelvin LEE ,  Abraham LENHOFF ,  Kristen VALENTE ,  Nick LEVY ,  Yatin GOKARN

Inventor： Kelvin LEE ,  Abraham LENHOFF ,  Kristen VALENTE ,  Nick LEVY ,  Yatin GOKARN

IPC: C12N15/113 ,  A61K38/39 ,  A61K38/17 ,  A61K38/44 ,  C12P21/00 ,  A61K38/48 ,  A61K38/45 ,  A61K38/42 ,  A61K47/26 ,  C07K16/00 ,  A61K38/52

CPC classification number: C12N15/1137 ,  A61K38/1709 ,  A61K38/1741 ,  A61K38/1761 ,  A61K38/1774 ,  A61K38/39 ,  A61K38/42 ,  A61K38/44 ,  A61K38/443 ,  A61K38/45 ,  A61K38/4813 ,  A61K38/482 ,  A61K38/488 ,  A61K38/52 ,  A61K47/26 ,  C07K16/00 ,  C12N9/20 ,  C12N2310/10 ,  C12N2310/14 ,  C12N2310/20 ,  C12P21/005 ,  C12P21/02 ,  C12Y104/03013 ,  C12Y111/01015 ,  C12Y205/01018 ,  C12Y207/04006 ,  C12Y207/11001 ,  C12Y301/01034 ,  C12Y304/16005 ,  C12Y304/21 ,  C12Y304/23005 ,  C12Y502/01008 ,  C12Y503/04001

Abstract: The invention relates a method for producing a stable recombinant protein, comprising growing a non-naturally occurring host cell in a culture medium to produce a recombinant protein, and making a composition comprising the recombinant protein and a polysorbate. The production of endogenous lipoprotein lipase by the host cell is reduced. The endogenous lipoprotein lipase is present in the composition in a small amount, and is capable of degrading the polysorbate. The invention also relates to the relevant host cells and compositions, and preparation thereof.

Abstract translation: 本发明涉及一种生产稳定重组蛋白的方法，包括在培养基中培养非天然存在的宿主细胞以产生重组蛋白，以及制备包含重组蛋白和聚山梨酯的组合物。 由宿主细胞产生的内源性脂蛋白脂肪酶降低。 内源性脂蛋白脂肪酶以少量存在于组合物中，并且能够降解聚山梨醇酯。 本发明还涉及相关宿主细胞和组合物及其制备。

公开(公告)号：US20080213282A1

公开(公告)日：2008-09-04

申请号：US12004114

申请日：2007-12-19

Applicant: Jaby Jacob ,  Masazumi Matsumura ,  Yatin Gokarn ,  David Brems

Inventor： Jaby Jacob ,  Masazumi Matsumura ,  Yatin Gokarn ,  David Brems

IPC: A61K39/395 ,  C07K16/18 ,  A61P25/00

CPC classification number: C07K16/22 ,  A61K9/0019 ,  A61K9/08 ,  A61K47/12 ,  A61K47/183 ,  A61K47/22 ,  C07K2317/94

Abstract: The invention provides a formulation comprising a buffer with a pH from about 4.0 to about 6.0, proline and an effective amount of a polypeptide. The polypeptide can be an antibody. The specification also provides methods of preparing the formulation, a kit containing the formulation and methods of using the formulation.

Abstract translation: 本发明提供一种包含pH为约4.0至约6.0的缓冲液，脯氨酸和有效量的多肽的制剂。 该多肽可以是抗体。 说明书还提供了制备制剂的方法，包含制剂的试剂盒和使用制剂的方法。

公开(公告)号：US20080003220A1

公开(公告)日：2008-01-03

申请号：US11788770

申请日：2007-04-19

Applicant: Yatin Gokarn

Inventor： Yatin Gokarn

IPC: A61K38/00 ,  A61K38/18 ,  A61K38/22 ,  A61K39/395 ,  A61P41/00

CPC classification number: C07K16/2803 ,  A61K9/0019 ,  A61K39/39591 ,  A61K47/12

Abstract: The invention provides a biopharmaceutical formulation including an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0, at least one excipient and an effective amount of a therapeutic polypeptide. The propionate buffer can include a concentration selected from between about 1-50 mM, 2-30 mM, 3-20 mM, 4-10 mM and 5-8 mM. The therapeutic polypeptide included in a biopharmaceutical formulation of the invention can include an antibody, Fd, Fv, Fab, F(ab′), F(ab)2, F(ab′)2, single chain Fv (scFv), chimeric antibodies, diabodies, triabodies, tetrabodies, minibody, peptibody, hormone, growth factor or cell signaling molecule. The invention also provides a method of preparing a biopharmaceutical formulation. The method includes combining an aqueous solution having a propionate buffer with a pH from about 4.0 to about 6.0 and at least one excipient with an effective amount of a therapeutic polypeptide.

Abstract translation: 本发明提供一种生物药物制剂，其包括具有约4.0至约6.0的pH的丙酸盐缓冲液，至少一种赋形剂和有效量的治疗性多肽的水溶液。 丙酸盐缓冲液可以包括选自约1-50mM，2-30mM，3-20mM，4-10mM和5-8mM之间的浓度。 包含在本发明的生物药物制剂中的治疗性多肽可以包括抗体Fd，Fv，Fab，F（ab'），F（ab）2，F（ab'）2 单链Fv（scFv），嵌合抗体，双抗体，三抗体，四体抗体，微型抗体，肽性抗体，激素，生长因子或细胞信号传导分子。 本发明还提供了制备生物药物制剂的方法。 该方法包括将具有丙酸盐缓冲液的水溶液与约4.0至约6.0的pH和至少一种赋形剂与有效量的治疗性多肽组合。