Regeneron Pharmaceuticals, Inc.

Regeneran Pharmaceuticals, Inc.

Mike Stelmah

Alexei Goraltchouk

Michael Cupicha

Bart E Burgess

Bryan Grygus

Rachel Paige Arnott

Ian Hart

Michael J Cupicha

The present disclosure provides aseptic vial piercing and sterilization systems, and methods of assembling, using and sterilizing same. The systems and methods utilize a pre-sterilized primary container including a first end, a first cavity, a second end with an opening in communication with the first cavity, a septum at least partially sealing the opening, and a product within the first cavity. The systems and methods include an injection assembly including a first end portion of a hollow flowpath forming member. The injection assembly and the primary container may be assembled in a non-sterile environment to form a second cavity extending about the first end portion of the flowpath forming member and to the primary container. The second cavity may then be selectively sterilized in a non-deleterious manner to the product to allow the first end portion to aseptically pierce the septum to extend into the first cavity.

Aseptic piercing system and method

A syringe system, piston seal systems, stopper systems, and methods for assembling and using the syringe systems. The piston seal system including a piston seal member and a piston head member. The injection system including a container, a piston seal system positioned within the container, and a stopper system coupled to an end of the container. The method of assembling an injection system, the method includes obtaining a container, a piston seal system, and a stopper system. The method also includes inserting the piston seal system into a cavity within the container. The method further includes securing the stopper system at an end of the container in an opening of the cavity. Methods of using the syringe system, piston seal systems, and stopper systems are also disclosed.

Syringe systems, piston seal systems, stopper systems, and methods of use and assembly

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Tarrytown, NY, United States of America

Mike Stelmah