Amgen Inc.

Clearant, Inc.

Ren-Yo Forng

Wael Mismar

Cheng-Chieh Chou

William N Drohan

Wilson H Burgess

Robert W Swift

David Mann

Martin J Macphee

Chia-Jung Wu

Jessica Hai Liu

Mingda Eu

Anna L McBain

Malak Guirguis

Olivia Alice Henderson

Teri Grieb

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

Methods are disclosed for sterilizing preparation of monoclonal immunoglobulins to reduce the level of active biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas, prions and parasites.

Methods for sterilizing preparations of monoclonal immunoglobulins

Growing community of inventors

Potomac, MD, United States of America

Ren-Yo Forng