Amgen Inc.

Wael Mismar

Shaun Robert Devitt

Scott Comiso

Kenneth Tan

Tark Abed

Mario Bogdan

Justin Allen Marsh

Anthony Bantug

Matthew Wayne Janke

Loic Barbedette

Jessica Hai Liu

Anthony Bitong

Sudeshna Dutta Ray

Chia-Jung Wu

Ren-Yo Forng

Malak Guirguis

Kenneth G Schalhoub

Mads Schjoth Due

Alexis Dechelette

Mingda Eu

Cheng-Chieh Chou

Sheldon B Moberg

Scott Robert Gibson

Ryan Michael Agard

Paul D Faucher

Daniel Eduardo Groszmann

Dylan Bourelle

Brian Schryver

Mehran Mojarrad

Ronald Forster

Thomas Clark Pearson

Andrew Nathan King

Jerome Olivas

Justin Harris

Owen Ryan

Martin Hering

Gregory Gordon

Robert Allen Dees

Greg Payne

Shermeen A Abbas

Rami Saifan

Tej Desai

Arin Keshishian

Chelsea Balli-Cruz

Pierre Burquel

Ryan Oba

Michael Gammelager

Mads Hansen

Clive Smith

Valerio Mazzon

Vial sleeve

A container and systems for use during an external sterilization process of a plurality of drug delivery devices are provided. The container may include an outer housing and at least one partition at least partially enclosed by the outer housing. The at least one partition may include a plurality of first dividers and a plurality of second dividers. The at least one partition may also be positioned an open configuration, wherein the plurality of first dividers and the plurality of second dividers cooperate with each other to define a plurality of chambers configured to receive at least one of the plurality of drug delivery devices. The at least one partition may also be positioned in a closed configuration wherein the plurality of chambers are substantially completely collapsed.

Containers and systems for use during external sterilization of drug delivery devices

Drug delivery devices, sealing members for containers housed within such drug delivery devices, and related methods of assembly are disclosed. The drug delivery device may include a housing, a container disposed in the housing and having an interior volume, a drug disposed in the interior volume, and a septum. The container may have an opening formed in an end surface and which communicates with the interior volume. The septum may include a proximal end inserted through the opening into the interior volume of the container. Additionally, the septum may include a distal end having a flange disposed outwardly of the proximal end and contacting the end surface of the container. At least an end portion of the flange may be made of a material that is permeable to a gaseous sterilizing agent.

Gas permeable sealing member for drug container and methods of assembly

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.

Method for external sterilization of drug delivery device

Fluid path assemblies for drug delivery devices and methods of establishing a fluid flow path for drug delivery devices are described that include a needle shield valve member that couples to a reservoir having a needle mounted thereto. The needle shield valve member includes an internal barrier that protects the needle and/or contains a drug within the reservoir until activation of the drug delivery device. Upon activation, there is relative movement between the reservoir and needle shield valve member until the needle pierces the barrier to establish a fluid flow path from the reservoir through the needle shield valve member.

Fluid path assembly for a drug delivery device

An injection device is provided, including a syringe having a barrel and a flange and a backstop configured to be coupled with the syringe adjacent to the flange. The backstop includes an inner surface generally extending around at least a portion of the syringe, wherein the inner surface includes at least one protrusion extending away from the inner surface and configured to engage the flange and/or the barrel to permit or promote airflow through a space between the inner surface and the syringe.

Injection device for drug delivery and packaging for the injection device

Fill-finish assemblies facilitating the manufacture of a drug delivery device are disclosed. The fill-finish assembly may include a container, an insertion mechanism, a fluid pathway connection assembly disposed between the container and the insertion mechanism, and a carrier. The insertion mechanism may include a delivery member and an insertion mechanism housing. The insertion mechanism may be configured to move the delivery member from a retracted position inside the insertion mechanism housing to a deployed position outside the insertion mechanism housing. The fluid pathway connection assembly may be selectively activatable to establish fluid communication between the container and the delivery member. The carrier may have a hollow interior containing at least a portion of each of the container, the insertion mechanism, and the fluid pathway connection assembly. The carrier may be configured to hold the container, the insertion mechanism, and the fluid pathway connection assembly in alignment with each other.

Fill-finish assemblies and related methods

A drug delivery sterilization system includes a housing defining at least one receptacle, a container assembly having first and second ends, an elongated portion extending therebetween, and an electron beam or x-ray generator disposed near the housing. The container assembly includes a container having a container contact region at the second end and an inner volume to contain a medicament, a seal member having a seal member contact region to form a sealing interface with the container contact region, and a coupling device adapted to sealingly couple the seal member to the container. The container assembly is at least partially disposed in the receptacle such that the second end of the container is exposed through the housing. The electron beam or x-ray generator generates a sterilizing beam that penetrates the seal member to sterilize the sealing interface.

Systems and approaches for sterilizing a drug delivery device

An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.

Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a housing, a container, a trigger member, and an interlock assembly. The trigger member may be selectively moveable relative to the housing to activate operation of at least one activatable element of the drug delivery device. The interlock assembly may include a lever mounted rotatably relative to the housing, a proximity sensor moveable between a first position extending beyond an exterior surface of the housing and a second position retracted toward the housing, and a rotational biasing member operably connected to the proximity sensor via the lever. When the proximity sensor is in the first position, the interlock assembly may limit movement of the trigger member relative to the housing. The rotational biasing member may be configured to exert a torque biasing the proximity sensor toward the first sensor position.

Drug delivery device including seal member for needle of syringe

Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a container including a wall with an interior surface and a seal member with an end surface. The interior surface of the wall and the end surface of the seal member may define a reservoir filled with a drug. A fluid pathway assembly may be connected to the container and include an overmold member that covers a length of a container access needle and which defines an enclosed space with the seal member. The overmold member may be moveable relative to the seal member to carry the container access needle between a storage position, where a point of the container access needle is disposed exterior to the reservoir, and a delivery position, where the point extends through the end surface of the seal member into the reservoir.

Drug delivery device with container access system and related method of assembly

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

Growing community of inventors

Redondo Beach, CA, United States of America

Wael Mismar