Other

Amgen Inc.

Biomarin Pharmaceutical Inc.

Bioventures, LLC

Helixmith Co., Ltd

Buzzard Pharmaceuticals Ab

Excelse Bio, Inc.

Integrity Bio, Inc.

Byeong Seon Chang

Roger Wongjung Liu

Jonathan LeBowitz

Lei Shi

Gregory Zarbis-Papastoitsis

Bruce A Kerwin

Patricia Lowden

Mayumi Nakagawa

The present invention provides a novel lyophilized pharmaceutical composition that maintains the stability of a DNA plasmid while forming a uniform and elegant cake during lyophilization. The novel lyophilization formulation further allows uniform reconstitution of the DNA plasmid in a pharmaceutically acceptable solution, enabling complete recover of the active ingredients, minimizing partial loss of potency and allowing administration of the active ingredients in an accurate and consistent manner. Additionally provided herein include methods of making the lyophilized pharmaceutical composition and methods of administering the composition for treatment of various diseases.

Lyophilized pharmaceutical compositions for naked DNA gene therapy

The present specification discloses a solution delivery device having a container component and a plug component configured for selective engagement with the container component. The container component has an internal cavity including an elongated mixing channel containing a first constituent, and the plug component provides an internal flow path configured for introduction of a second constituent into the mixing channel for mixing with the first constituent. The plug component may be inserted within the container component partially in a first operational mode and fully in a second operational mode. The first constituent may be a drug and the second constituent a diluent, such that the drug may be lyophilized with the device in the first operational mode and reconstituted with the device in the second operational mode. Multiple devices may be employed in tandem for the co-delivery of multiple constituents. The device may be included in a kit or installed within an injector.

Solution delivery device and method

Featured herein are vehicle formulations and formulations containing a chimeric cytokine designed for e.g., ocular delivery.

Chimeric cytokine formulations for ocular delivery

A container usable for lyophilization, storage, and reconstitution of medication having only two parts, one of which is a plug component having a flow path terminating in a side outlet port and a second of which is a barrel component. The barrel component has a spiral mixing channel near its distal end in which powder medication is stored and upon reconstitution, yields a gradient concentration. The inner wall of the barrel includes a longitudinal diluent groove. To connect the plug outlet port with the longitudinal diluent groove, the plug or barrel has a 360&#xb0; distribution groove encircling the plug and connecting to the plug outlet port. Regardless of what rotational orientation the plug has to the barrel, the diluent will always reach the mixing channel.

Compact medication reconstitution device and method

Peptides and compositions for a therapeutic vaccine to treat persons infected with human papilloma virus are presented. Methods of using the compositions and treating persons infected with human papilloma virus, including those at risk of cancer or already with cancer from human papilloma virus, are presented.

Human Papilloma virus therapeutic vaccine

Provided are stable protein formulations that contain at least one amino acid. In certain embodiments, amino acid combinations either at least two, or three, or four, or more amino acids are included. By virtue of inclusion of the amino acids, the formulation has low viscosity and a protein in the formulations is physically, chemically, and biological stable even at high concentrations. In further embodiments, by virtue of inclusion of the amino acids, a protein in the formulations is physically, chemically, and biological stable even at high concentrations.

Protein formulations containing amino acids

A container closure delivery system that is suitable for lyophilized pharmaceutical injectable powder products is disclosed. The system comprises storage stable powder formulations and a container closure assembly design wherein the formulation can be filled and lyophilized with a standard fill finish equipment, and the formulations and lyophilization processes are optimized to produce a powder that readily dissolves upon contact with a diluent, thereby facilitating the direct injection of the lyophilized product without the need for a separate reconstitution/mixing/priming step.

Method for storing and delivering a drug

The present invention provides improved formulations for lysosomal enzymes useful for enzyme replacement therapy. Among other things, the present invention provides formulations that preserve or enhance the stability and/or efficacy of a lysosomal enzyme such as acid alpha-glucosidase.

Formulations for lysosomal enzymes

A method of storing and delivery a drug, such as by lyophilizing and reconstituting, comprises performing both storing and delivering with the same container closure assembly. The container closure is assembled in a preparation configuration during which lyophilization occurs. After lyophilizing, the powdered drug is forced into a spiral channel in the container closure assembly by a plunger. The plunger leaves substantially no head space for the powdered drug, and the assembly is sealed thereby now being in the storage configuration. For delivery of the stored powdered drug, a syringe of diluent is introduced to the container assembly thereby changing the assembly to the delivery configuration. The spiral channel is continuous between an input end and a delivery end with the delivery end being in fluid communication with a delivery outlet of the assembly. The assembly includes a diluent flow path that forces the diluent into a spiral channel at only the input end. As the diluent is forced to flow through the spiral channel from the input end to the delivery end, it reconstitutes the powdered drug, thereby reconstituting and delivering in the same step. No separate reconstituting and priming steps are needed.

Container closure delivery system

The present invention provides for improved compositions comprising a PEGsTNF-R1 which, in addition to having useful higher concentrations, demonstrate decreased viscosity (&#x3c;400 cP) and improved stability.

Growing community of inventors

Sherman Oaks, CA, United States of America

Byeong Seon Chang