Abstract: The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

Abstract: The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

Abstract: A primary packaging for storage and/or administration of medical or pharmaceutical compounds includes a container that has a predetermined filling volume for receiving a medical or pharmaceutical compound. The container is permanently closed at a first end and has an integrally formed, circumferential flange portion at an open second end. The container has a cylindrical barrel that extends between the first end and the flange portion such that the barrel has an inner diameter and outer diameter corresponding to that of a standardized syringe for a nominal volume of the standardized syringe corresponding to the predetermined filling volume. Furthermore, a cross-sectional shape of the flange portion corresponds to the cross-sectional shape of a flange of a standardized vial. The primary packaging also includes a closure element that is adapted to fit tightly on the flange portion and into the barrel for sealing the open second end of the container.

Abstract: A delivery system for medical and pharmaceutical compounds includes a container, a closure element, a supporting element and a penetration element. The container contains the compounds and has a closed container bottom and an open second end. The closure element makes fluid-tight contact with the inner wall of the container. The supporting element attaches to the closure element. The penetration element has a hollow needle and moves along the longitudinal axis of the container. The penetration element includes a first link motion portion, and the supporting element includes a second link motion portion. The first link motion portion has a guiding groove, and the second link motion portion has a projection. The hollow needle of the penetration element moves towards the container bottom and penetrates the closure element. The penetration element moves inside the supporting element towards the container bottom based on how the projection travels in the guiding groove.

Abstract: A delivery system for delivering medical or pharmaceutical compounds includes a container, a closure element, an attachment element and a penetration element. The container contains the compounds and has a closed container bottom and an open second end. The closure element makes fluid-tight contact with the inner wall of the container. The penetration element has a hollow needle and moves along the longitudinal axis of the container. The penetration element includes a first link motion portion, and the attachment element includes a second link motion portion. One of the link motion portions is a projection, and the other is a guiding groove. As the projection moves in the guiding groove, the hollow needle of the penetration element moves towards the container bottom and penetrates the closure element. The penetration element moves inside the attachment element towards the container bottom based on how the projection travels in the guiding groove.

Abstract: A primary packaging for storage and/or administration of medical or pharmaceutical compounds includes a container that has a predetermined filling volume for receiving a medical or pharmaceutical compound. The container is permanently closed at a first end and has an integrally formed, circumferential flange portion at an open second end. The container has a cylindrical barrel that extends between the first end and the flange portion such that the barrel has an inner diameter and outer diameter corresponding to that of a standardized syringe for a nominal volume of the standardized syringe corresponding to the predetermined filling volume. Furthermore, a cross-sectional shape of the flange portion corresponds to the cross-sectional shape of a flange of a standardized vial. The primary packaging also includes a closure element that is adapted to fit tightly on the flange portion and into the barrel for sealing the open second end of the container.

Abstract: The present invention relates to a method of producing syringes. Said method comprises fixing a needle to a syringe body by use of an adhesive followed by subjecting the syringes thus obtained to heat treatment. The invention further relates to a method of reducing leachables and/or extractables in prefilled syringes, said method comprising heat treating pre-fabricated syringes at a temperature of at least 40° C. before filling.

Abstract: A delivery system for delivering medical or pharmaceutical compounds includes a container, a closure element, an attachment element and a penetration element. The container contains the compounds and has a closed container bottom and an open second end. The closure element makes fluid-tight contact with the inner wall of the container. The penetration element has a hollow needle and moves along the longitudinal axis of the container. The penetration element includes a first link motion portion, and the attachment element includes a second link motion portion. One of the link motion portions is a projection, and the other is a guiding groove. As the projection moves in the guiding groove, the hollow needle of the penetration element moves towards the container bottom and penetrates the closure element. The penetration element moves inside the attachment element towards the container bottom based on how the projection travels in the guiding groove.

Abstract: A delivery system for medical and pharmaceutical compounds includes a container, a closure element, a supporting element and a penetration element. The container contains the compounds and has a closed container bottom and an open second end. The closure element makes fluid-tight contact with the inner wall of the container. The supporting element attaches to the closure element. The penetration element has a hollow needle and moves along the longitudinal axis of the container. The penetration element includes a first link motion portion, and the supporting element includes a second link motion portion. The first link motion portion has a guiding groove, and the second link motion portion has a projection. The hollow needle of the penetration element moves towards the container bottom and penetrates the closure element. The penetration element moves inside the supporting element towards the container bottom based on how the projection travels in the guiding groove.

Abstract: The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

Abstract: A primary packaging for storage and/or administration of medical or pharmaceutical compounds includes a container that has a predetermined filling volume for receiving a medical or pharmaceutical compound. The container is permanently closed at a first end and has an integrally formed, circumferential flange portion at an open second end. The container has a cylindrical barrel that extends between the first end and the flange portion such that the barrel has an inner diameter and outer diameter corresponding to that of a standardized syringe for a nominal volume of the standardized syringe corresponding to the predetermined filling volume. Furthermore, a cross-sectional shape of the flange portion corresponds to the cross-sectional shape of a flange of a standardized vial. The primary packaging also includes a closure element that is adapted to fit tightly on the flange portion and into the barrel for sealing the open second end of the container.

Abstract: The present invention provides a method for preparation of a high concentration liquid formulation (HCLF) of an antibody or a fragment thereof. The present invention also relates to a method for stabilizing an anti-CD20 antibody or a fragment thereof in a liquid pharmaceutical formulation. Furthermore, the present invention relates to a liquid pharmaceutical formulation of a veltuzumab antibody or a fragment thereof comprising at least 155 mg/mL of a veltuzumab antibody or a fragment thereof.

Abstract: The present invention relates to a method of producing syringes. Said method comprises fixing a needle to a syringe body by use of an adhesive followed by subjecting the syringes thus obtained to heat treatment. The invention further relates to a method of reducing leachables and/or extractables in prefilled syringes, said method comprising heat treating pre-fabricated syringes at a temperature of at least 40° C. before filling.

Abstract: The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

Abstract: The present invention relates to a method of producing syringes. Said method comprises fixing a needle to a syringe body by use of an adhesive followed by subjecting the syringes thus obtained to heat treatment. The invention further relates to a method of reducing leachables and/or extractables in prefilled syringes, said method comprising heat treating pre-fabricated syringes at a temperature of at least 40° C. before filling.

Abstract: The present invention provides a method for preparation of a high concentration liquid formulation (HCLF) of an antibody or a fragment thereof. The present invention also relates to a method for stabilizing an anti-CD20 antibody or a fragment thereof in a liquid pharmaceutical formulation. Furthermore, the present invention relates to a liquid pharmaceutical formulation of a veltuzumab antibody or a fragment thereof comprising at least 155 mg/mL of a veltuzumab antibody or a fragment thereof.

Abstract: The present invention relates to a method of producing syringes. Said method comprises fixing a needle to a syringe body by use of an adhesive followed by subjecting the syringes thus obtained to heat treatment. The invention further relates to a method of reducing leachables and/or extractables in prefilled syringes, said method comprising heat treating pre-fabricated syringes at a temperature of at least 40° C. before filling.

Abstract: The invention relates to highly stable aqueous G-CSF-containing compositions that contain succinate and/or tartrate as the buffer substances. The invention further concerns lyophilisates and powders that are obtainable from such compositions, and to pharmaceutical kits containing such lyophilisates and powders.