公开(公告)号：WO2020167541A1

公开(公告)日：2020-08-20

申请号：PCT/US2020/016714

申请日：2020-02-05

Applicant: AMGEN INC.

Inventor： WU, Chia-Jung ,  CLARK, Nicholas J. ,  MAHESHWARI, Ronak ,  FRANEY, Heather N.

IPC: A61M5/14 ,  A61M39/10 ,  A61M5/142 ,  A61M5/148 ,  A61J1/10 ,  A61J1/14 ,  A61J1/16 ,  A61J1/20

Abstract: A drug delivery system includes a delivery container, a first drug insertion port, at least one additional drug insertion port, and an IV connection port. The delivery container includes upper, lower, first side, and second side portions, and further includes a tapered region extending between the first side portion and the second side portion. The first drug insertion port is positioned at the lower portion of the delivery container and has a first coupling mechanism. The at least one additional drug insertion port is also positioned at the lower portion of the delivery container, but includes a second coupling mechanism that is different than the first coupling mechanism. The IV connection port is positioned at the lower portion of the delivery container adjacent to a lower portion of the tapered region.

公开(公告)号：WO2021056020A1

公开(公告)日：2021-03-25

申请号：PCT/US2020/070545

申请日：2020-09-16

Applicant: AMGEN INC.

Inventor： MISMAR, Wael ,  LIU, Jessica Hai ,  WU, Chia-Jung ,  ABBAS, Shermeen A. ,  DEVITT, Shaun ,  SCHALHOUB, Kenneth G. ,  BITONG, Anthony ,  DUE, Mads Schjoth ,  GUIRGUIS, Malak ,  SAIFAN, Rami

IPC: A61M5/00 ,  A61M5/31

Abstract: A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2) is provided, including placing the drug delivery device in a sterilization chamber, introducing into the chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying a vacuum level of between about 10 and 600 Torr and holding the vacuum level for a dwell time of between about 2 and 20 minutes, repeating the step of introducing into the chamber a dose of NO2 for a number of pulses between about 1 and 24, purging the sterilization chamber of at least substantially all of the NO2, and aerating the sterilization chamber.

公开(公告)号：WO2021081321A1

公开(公告)日：2021-04-29

申请号：PCT/US2020/057054

申请日：2020-10-23

Applicant: AMGEN INC.

Inventor： POMPE, Cornelius ,  CLARK, Nicholas, J. ,  QI, Wei ,  MCAULEY, Arnold, J. ,  SCHNEIDER, Michael ,  WU, Chia-Jung ,  CHRISTIAN, Twinkle, R. ,  FRANEY, Heather, N. ,  JAGANNATHAN, Bharadwaj ,  ABEL, Jeffrey ,  DIETZEL, Franz

IPC: G01N24/08 ,  G01N33/15 ,  A61M5/142

Abstract: An approach for determining material compatibility for components of a drug delivery system is provided that includes using surface zeta-potential analytical method to evaluate surface interactions between a desired molecule and at least one material present within a given IV-bag system.

公开(公告)号：WO2020167910A1

公开(公告)日：2020-08-20

申请号：PCT/US2020/017874

申请日：2020-02-12

Applicant: AMGEN INC.

Inventor： CLARK, Nicholas, J. ,  WU, Chia-Jung ,  EU, Mingda ,  ALANIS, Artemio, A. ,  SAWICKY, Jennifer, Lyn ,  GOSS, Monica, Michelle ,  STEVENSON, Jennifer ,  FRANEY, Heather, N. ,  PIEDMONTE, Deirdre ,  BRYCH, Stephen, Robert

IPC: A61J1/20 ,  A61M39/00

Abstract: An approach for preparing a drug delivery device includes providing a prefilled delivery container and transferring a drug product contained in a drug container to the prefilled delivery container. The prefilled delivery container includes a container body containing a predetermined quantity of saline solution and a predetermined quantity of IV stabilizing solution ("IVSS"). The drug product is transferred to the prefilled delivery container via a delivery container adapter.