A sealed pharmaceutical container includes a shoulder, a neck extending from the shoulder, and a flange extending from the neck. The flange includes an inclined sealing surface defining an opening in the sealed pharmaceutical container. The sealed pharmaceutical container also includes a sealing assembly including a stopper extending over the sealing surface of the flange and a cap securing the stopper to the flange. The stopper has a glass transition temperature (T.sub.g) that is greater than or equal to −70° C. and less than or equal to −45° C. The sealing assembly maintains a helium leakage rate of the sealed pharmaceutical container of less than or equal to 1.4×10.sup.−6 cm.sup.3/s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −45° C.

A glass vial includes a base including a boron-containing multicomponent glass and a vial opening and holds a liquid active pharmaceutical ingredient formulation. The glass vial has a total volume of <4.5 mL. A filling level of the glass vial with the active pharmaceutical ingredient formulation is not more than 0.25 and a concentration of boron ions, measured at a measurement site below a plane of a middle of the glass vial using a concentration depth profile at a depth in a range from 10 to 30 nm, has a value, averaged over the measurements of the concentration depth profile, that has an excess increase of not more than 30% compared to a concentration of boron ions measured using a concentration depth profile at a depth in a range from 10 to 30 nm with a measurement site in the plane of the middle of the glass vial.

A biobased polymer composition for pharmaceutical articles includes a low density polyethylene, in which at least a portion of ethylene is obtained from a renewable source of carbon. The biobased polymer composition exhibits an Emission Factor ranging from −3.5 to 0 kg CO2.sub.e/kg of the biobased polymer composition, and is biocompatible for use in pharmaceutical packaging. A pharmaceutical article includes the biobased polymer composition and has a volume ranging from 0.04 ml to 10000 ml. A method for forming a pharmaceutical article includes extruding the biobased polymer composition at a temperature ranging from 100 to 250° C. and at a screw speed ranging from 20 to 100 rpm. A method for producing a biobased polymer composition includes polymerizing ethylene at least partially obtained from a renewable source of carbon to form a low density polyethylene.

A quartz glass container is shown and described herein. The quartz glass container exhibits a low concentration of surface defects on an inner surface of the container. In aspects hereof, the container may have a surface defect density of 50 or fewer surface defects per square centimeter within a 1 cm band centered 1 cm from the base of the container.

The embodiments of the present disclosure provide a pierceable stopper, comprising a plug portion, and a disk portion disposed on top of the plug portion and comprising a flange extending radially beyond an outer diameter of the plug portion. The embodiments also provide a lyophilization stopper, comprising a body comprising an integral hinge means, and a flange extending radially beyond an outer diameter of the body. Additionally, the embodiments provide a probe assembly, comprising a first needle comprising a hollow cavity and a pointed tip, and a second needle disposed inside the hollow cavity and comprising a rounded tip. The embodiments further provide a cartridge assembly, comprising a first housing comprising a first set of cavities configured to accommodate one or more containers, and a second housing comprising a second set of cavities corresponding to the first set of cavities when the second housing is coupled to the first housing.

The present invention concerns fixed dosing of HER antibodies, such as Pertuzumab.

A fluid delivery manifold system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular manifold design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular manifold construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery manifold configurations that meet specific needs (i.e., different modes of delivery depending on agent to be delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery).

A fluid delivery manifold system assembled and configured to allow delivery of a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular manifold design consisting of separately constructed components cooperatively arranged and coupled to one another. The modular manifold construction allows for rapid manufacturing reconfigurations of one or more components with minimal costs to create new delivery manifold configurations that meet specific needs (i.e., different modes of delivery depending on agent to be delivered, such as subcutaneous, intramuscular, intradermal, intravenous injection, spray, or droplet delivery).

A method for preparing a pre-filled multi-chamber injection system includes providing an injection system body, the injection system body defining an open proximal end, a body interior, and an open distal end. The method also includes introducing a first substance into a distal end of the body interior. The method further includes disposing a distal stopper member in the body interior, the distal stopper member and the injection system body defining proximal and distal chambers in the body interior. Moreover, the method includes introducing a second substance into the body interior. In addition, the method includes disposing a proximal stopper member in the body interior. The method also includes inserting an elongate member at least partially into the body interior, the elongate member having a plurality of flow channels for fluidly coupling the proximal and distal chambers. The method further includes coupling a plunger member to the proximal stopper member.

A vial blinding assembly includes a vial having a bottle with a constricted neck and an annular shoulder that inwardly extends; a stopper disposed on an opening of the bottle and having a septum with a top surface; and a retainer securing the stopper to the bottle. A tubular blinding shell encircles a compartment that extends between a first end with an inlet opening and an opposing second end with an access opening. A floor plug is secured to the first end of the blinding shell. The vial is disposed within compartment of the blinding shell with the vial being supported by the floor plug and the neck passing through the access opening so that the top surface of the septum is disposed outside of the compartment of the blinding shell, the shoulder of the vial having an outside diameter larger than a diameter of the access opening.