Abstract: The invention relates to a method for reducing an amount of sub visible particles in a pharmaceutical composition contained in a medical injection device comprising a container (1) including a barrel (10) lubricated with a lubricant coating (2) in contact with the pharmaceutical composition, and a stopper (14) in sliding engagement within the barrel (10), the container comprising a region (130, 121, 123) extending distally from the distal end (100) of the barrel which is not accessible to the stopper. During formation of said lubricant coating (2) on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into said region (130, 121, 123) extending distally from the distal end (100) of the barrel.

Abstract: The invention relates to a method for reducing an amount of sub visible particles in a pharmaceutical composition contained in a medical injection device comprising a container (1) including a barrel (10) lubricated with a lubricant coating (2) in contact with the pharmaceutical composition, and a stopper (14) in sliding engagement within the barrel (10), the container comprising a region (130, 121, 123) extending distally from the distal end (100) of the barrel which is not accessible to the stopper. During formation of said lubricant coating (2) on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into said region (130, 121, 123) extending distally from the distal end (100) of the barrel.

Abstract: Provided herein is a method to mimic and assess the chemical degradation risk of a biological product, in prefilled syringes (PFS), using a custom-designed mimetic peptide. Such method is also able to predict the susceptibility to degradation of biological product in solution in a container for medical usage.

Abstract: The present disclosure relates to a connector for connecting a medical injection device to a container closed by a septum. The connector has a distal tip and a sleeve extending around the tip. The sleeve has an inner threaded portion. The connector includes a proximal part configured to engage the tip of the injection device. The proximal part includes an outer threaded portion configured to be removably screwed to the inner threaded portion of the sleeve, distal part configured to be connected to the container, and a hollow spike extending from the proximal part. The hollow spike has an internal volume in fluidic connection with the injection device and perforates the septum of the container when the distal part is connected to the container. The spike includes an opening in a distal end being configured to create a connection between the medical injection device and the container.

Abstract: Disclosed herein is a method to evaluate the stability of a protein-based formulation including a protein, a peptide and/or a protein derivative and a buffer relative to a lubricant of a lubricated container in which the formulation is intended to be stored, including: a) Evaluating a decrease over time of interfacial tension between the buffer and the lubricant, b) Evaluating a decrease over time of interfacial tension between the protein-based formulation and the lubricant, c) Identifying at least one component of the protein-based formulation interacting with the lubricant by comparing the decrease evaluated in step b) with the decrease evaluated in step a).

Abstract: Provided herein is a method to mimic and assess the chemical degradation risk of a biological product, in prefilled syringes (PFS), using a custom-designed mimetic peptide. Such method is also able to predict the susceptibility to degradation of biological product in solution in a container for medical usage.

Abstract: The invention relates to a method for reducing an amount of sub visible particles in a pharmaceutical composition contained in a medical injection device comprising a container (1) including a barrel (10) lubricated with a lubricant coating (2) in contact with the pharmaceutical composition, and a stopper (14) in sliding engagement within the barrel (10), the container comprising a region (130, 121, 123) extending distally from the distal end (100) of the barrel which is not accessible to the stopper. During formation of said lubricant coating (2) on the inner wall of the barrel, the method comprises limiting lubricant from being deposited into said region (130, 121, 123) extending distally from the distal end (100) of the barrel.

Abstract: The invention relates to a method to evaluate the stability of a protein-based formulation comprising a protein, a peptide and/or a protein derivative and a buffer relative to a lubricant of a lubricated container in which said formulation is intended to be stored, comprising: a) Evaluating a decrease over time of interfacial tension between the buffer and the lubricant, b) Evaluating a decrease over time of interfacial tension between the protein-based formulation and the lubricant, c) Identifying at least one component of the protein-based formulation interacting with the lubricant by comparing the decrease evaluated in step b) with the decrease evaluated in step a).

Abstract: Provided herein is a method for storing an emulsion-adjuvanted vaccine in a medical injection device having a lubricant coating, said method including the steps of: (a) providing a medical injection device having a barrel having an inner surface; (b) forming a silicone oil layer on at least a part of the inner surface of the barrel that is intended to be in contact with the vaccine; (c) carrying out an oxidizing plasma treatment of the layer so as to crosslink at least part of the silicone oil layer and form a lubricant coating; and (d) filling the barrel with the emulsion-adjuvanted vaccine. The invention also relates to a medical injection device obtained directly from this method and to the use of plasma-treated silicone oil as a lubricant coating.

Abstract: This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and non-ionic surfactant.

Abstract: This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and a non-ionic surfactant.

Abstract: This invention relates to methods for evaluating or inhibiting the aggregation of a protein in an aqueous suspension including organopolysiloxane and medical articles coated with organopolysiloxane containing a protein solution including sugar and a non-ionic surfactant.