公开(公告)号：US10011643B2

公开(公告)日：2018-07-03

申请号：US14990948

申请日：2016-01-08

申请人： ASAHI KASEI PHARMA CORPORATION

发明人： Fumihide Nishio ,  Takuji Maejima ,  Yoshiro Mitome

IPC分类号： A61K38/22 ,  A61K9/19 ,  C07K14/635 ,  F26B5/06 ,  G01N30/88 ,  G01N33/68 ,  A61K38/29 ,  B65B55/10 ,  B65B55/12 ,  B65B63/08 ,  G01N30/72

CPC分类号： C07K14/635 ,  A61K9/19 ,  A61K38/29 ,  B65B55/10 ,  B65B55/12 ,  B65B63/08 ,  G01N30/7233

摘要： [Problem] Provided is a freeze-dried preparation containing high-purity PTH peptide and a method for the production thereof. Also provided is a test method for PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like.[Solution] In the present invention, the presence of PTH analogs produced during the manufacturing process of a freeze-dried preparation containing PTH peptide was confirmed. The production of these PTH analogs was also discovered to be markedly prevented or reduced by controlling exposure of the solution containing PTH peptide and the like to air environments within a pharmaceutical production facility.

公开(公告)号：US20160145316A1

公开(公告)日：2016-05-26

申请号：US14990948

申请日：2016-01-08

申请人： ASAHI KASEI PHARMA CORPORATION

发明人： Fumihide Nishio ,  Takuji Maejima ,  Yoshiro Mitome

IPC分类号： C07K14/635 ,  B65B63/08 ,  B65B55/10 ,  G01N30/72 ,  B65B55/12

CPC分类号： C07K14/635 ,  A61K9/19 ,  A61K38/29 ,  B65B55/10 ,  B65B55/12 ,  B65B63/08 ,  G01N30/7233

摘要： [Problem] Provided is a freeze-dried preparation containing high-purity PTH peptide and a method for the production thereof. Also provided is a test method for PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like.[Solution] In the present invention, the presence of PTH analogs produced during the manufacturing process of a freeze-dried preparation containing PTH peptide was confirmed. The production of these PTH analogs was also discovered to be markedly prevented or reduced by controlling exposure of the solution containing PTH peptide and the like to air environments within a pharmaceutical production facility.

摘要翻译： [问题]提供含有高纯度PTH肽的冷冻干燥制剂及其制造方法。 还提供了PTH类似物的测试方法，以确认含有PTH肽的冷冻干燥制剂的纯度等。 [解决方案]在本发明中，确认了在含有PTH肽的冷冻干燥制剂的制造过程中产生的PTH类似物的存在。 通过控制含有PTH肽等的溶液暴露于药物生产设备内的空气环境，也发现了这些PTH类似物的生产被显着地防止或减少。

公开(公告)号：US10683335B2

公开(公告)日：2020-06-16

申请号：US15991485

申请日：2018-05-29

申请人： ASAHI KASEI PHARMA CORPORATION

发明人： Fumihide Nishio ,  Takuji Maejima ,  Yoshiro Mitome

IPC分类号： A61K38/22 ,  A61K9/19 ,  C07K14/635 ,  F26B5/06 ,  G01N30/88 ,  G01N33/68 ,  A61K38/29 ,  B65B55/10 ,  B65B55/12 ,  B65B63/08 ,  G01N30/72

摘要： Provided herein are freeze-dried preparations comprising a high-purity parathyroid hormone (PTH) peptide and one or more PTH analogs, and methods for the production thereof. Also provided is a test method for detecting PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like.