公开(公告)号：US20180179545A1

公开(公告)日：2018-06-28

申请号：US15897290

申请日：2018-02-15

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

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

IPC分类号： 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分类号： 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

摘要： 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

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

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

IPC分类号： 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

摘要： 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

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

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

IPC分类号： 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分类号： 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

摘要： 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：US20080213282A1

公开(公告)日：2008-09-04

申请号：US12004114

申请日：2007-12-19

申请人： Jaby Jacob ,  Masazumi Matsumura ,  Yatin Gokarn ,  David Brems

发明人： Jaby Jacob ,  Masazumi Matsumura ,  Yatin Gokarn ,  David Brems

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

CPC分类号： C07K16/22 ,  A61K9/0019 ,  A61K9/08 ,  A61K47/12 ,  A61K47/183 ,  A61K47/22 ,  C07K2317/94

摘要： 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.

摘要翻译： 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

申请人： Yatin Gokarn

发明人： Yatin Gokarn

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

CPC分类号： C07K16/2803 ,  A61K9/0019 ,  A61K39/39591 ,  A61K47/12

摘要： 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.

摘要翻译： 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。