公开(公告)号：US20150307606A1

公开(公告)日：2015-10-29

申请号：US14650605

申请日：2013-12-09

Applicant: Ashwin BASARKAR ,  Akhilesh BHAMBHANI ,  Ramesh KASHI ,  Shona P. MEHTA ,  MERCK SHARP & DOHME CORP.

Inventor： Ashwin Basarkar ,  Akhilesh Bhambhani ,  Ramesh Kashi ,  Shona P. Mehta

IPC: C07K16/24 ,  F26B5/06 ,  A61K9/19

CPC classification number: C07K16/244 ,  A61K9/0019 ,  A61K9/1688 ,  A61K9/19 ,  A61K39/39591 ,  C07K2317/565 ,  C07K2317/94 ,  F26B5/06

Abstract: Methods for preparing lyophilized pellets of antibodies that specifically bind to human IL-23 are described. The pellets have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a flat, solid surface, in particular, a surface that does not have any cavities, followed by lyophilizing the frozen droplets. These methods are useful for preparing lyophilized pellets having a high concentration of anti-IL-23 antibody, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials. Also provided are improved formulations for use in preparing lyophilized forms of antibodies that specifically bind to human IL-23.

Abstract translation: 描述了制备特异性结合人IL-23的抗体冻干颗粒的方法。 颗粒具有基本上球形的形状，并且通过在平坦的固体表面，特别是没有任何空腔的表面上冷冻所需生物材料的液体组合物的液滴，然后冻结冷冻液滴来制备。 这些方法可用于制备具有高浓度抗IL-23抗体的冻干颗粒，并且比在小瓶中制备的冻干粉饼具有更快的重构时间。 还提供了用于制备特异性结合人IL-23的抗体的冻干形式的改进制剂。

公开(公告)号：US09649383B2

公开(公告)日：2017-05-16

申请号：US14443557

申请日：2013-11-15

Applicant: MERCK SHARP & DOHME CORP.

Inventor： Ramesh S. Kashi ,  Shona P. Patel ,  Sarita Mittal ,  Ashwin Basarkar ,  Shuai Shi

IPC: A61K38/17 ,  A61K47/26 ,  A61K47/18 ,  A61K47/12 ,  A61K47/22 ,  A61K47/02 ,  C07K14/715

CPC classification number: A61K47/26 ,  A61K38/1793 ,  A61K47/02 ,  A61K47/12 ,  A61K47/183 ,  A61K47/22 ,  C07K14/7151 ,  C07K2319/30

Abstract: The invention provides stable liquid formulations for a recombinant biopharmaceutical protein comprising a soluble form of the human p75 TNF receptor fused to an Fe domain of a human immunoglobulin protein (TNFR:Fc). Typically, biopharmaceutical proteins such as monoclonal antibodies (mAbs) and immunoglobulin fusion proteins (e.g., immunoadhesion proteins) are produced by recombinant DNA technology in mammalian cell expression systems. In order to guarantee the reproducible clinical performance of a biopharmaceutical product, manufacturers have to deliver a product of consistent and reproducible quality.

公开(公告)号：US20200147213A1

公开(公告)日：2020-05-14

申请号：US16609612

申请日：2018-05-01

Applicant: Merck Sharp & Dohme Corp.

Inventor： Manoj K. Sharma ,  Wendy Benjamin ,  Sarita Mittal ,  Ashwin Basarkar ,  Chakravarthy Nachu Narasimhan ,  Ramesh S. Kashi ,  Mohammed Shameem ,  Soumendu Bhattacharya ,  William P. Forrest, JR. ,  Yogita Krishnamachari

IPC: A61K39/395 ,  A61K47/26 ,  A61K47/34 ,  A61K47/18 ,  A61K9/19

Abstract: The invention relates to stable formulations of antibodies against human programmed death receptor PD-1, or antigen binding fragments thereof. In some embodiments the formulations of the invention comprise between 5-200 mg/mL anti-PD-1 antibody, or antigen binding fragment thereof. The invention further provides methods for treating various cancers with stable formulations of the invention. In some embodiments of the methods of the invention, the formulations are administered to a subject by intravenous or subcutaneous administration.

公开(公告)号：US20190010224A1

公开(公告)日：2019-01-10

申请号：US16064721

申请日：2016-12-20

Applicant: NARASIMHAN Narasimhan ,  Ashwin BASARKAR ,  Soumendu BHATTACHARYA ,  Wendy BENJAMIN ,  Mohammed SHAMEEM ,  Merck Sharp & Dohme Corp.

Inventor： Chakravarthy Nachu Narasimhan ,  Ashwin Basarkar ,  Soumendu Bhattacharya ,  Wendy Benjamin ,  Mohammed Shameem

IPC: C07K16/24 ,  A61P35/00 ,  A61K9/19 ,  A61K47/12 ,  A61K47/36 ,  A61K47/18

Abstract: The present invention provides formulations of anti-IL-10 hum12G8, and their use in treating various disorders.

公开(公告)号：US20150290325A1

公开(公告)日：2015-10-15

申请号：US14443557

申请日：2013-11-15

Applicant: MERCK SHARP & DOHME CORP.

Inventor： Ramesh S. Kashi ,  Shona P. Patel ,  Sarita Mittal ,  Ashwin Basarkar ,  Shuai Shi

IPC: A61K47/26 ,  A61K47/18 ,  A61K47/12 ,  A61K47/22 ,  A61K38/17 ,  A61K47/02

CPC classification number: A61K47/26 ,  A61K38/1793 ,  A61K47/02 ,  A61K47/12 ,  A61K47/183 ,  A61K47/22 ,  C07K14/7151 ,  C07K2319/30

Abstract: The invention provides stable liquid formulations for a recombinant biopharmaceutical protein comprising a soluble form of the human p75 TNF receptor fused to an Fe domain of a human immunoglobulin protein (TNFR:Fc). Typically, biopharmaceutical proteins such as monoclonal antibodies (mAbs) and immunoglobulin fusion proteins (e.g., immunoadhesion proteins) are produced by recombinant DNA technology in mammalian cell expression systems. In order to guarantee the reproducible clinical performance of a biopharmaceutical product, manufacturers have to deliver a product of consistent and reproducible quality.

Abstract translation: 本发明提供用于重组生物药物蛋白质的稳定液体制剂，其包含与人免疫球蛋白（TNFR：Fc）的Fe结构域融合的人p75 TNF受体的可溶形式。 通常，通过重组DNA技术在哺乳动物细胞表达系统中产生生物制药蛋白，例如单克隆抗体（mAb）和免疫球蛋白融合蛋白（例如免疫粘附蛋白）。 为了保证生物制药产品的可重现的临床表现，制造商必须提供一致和可重复品质的产品。