Abstract: The present invention relates to a cell-based reporter assay for determining viral potency comprising A) transfecting cells maintained in media with a promoter-reporter construct and generating reporter enzyme within the cells; B) infecting cells with a live virus or live virus vaccine wherein reporter enzyme is released into media; and C) measuring reporter enzyme intensity in media.

Abstract: The present invention relates to a method of vaccinating a patient against varicella zoster virus (VZV) by delivery of an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of a patient's skin at a depth of between about 100 and about 700 microns from the surface of the skin, which is useful for preventing herpes zoster or reducing the severity or duration thereof. In embodiments of the invention, the patient is 50 years of age or older and has been previously exposed to VZV. The invention also relates to a method of preventing VZV infection in an individual who was not previously infected with VZV comprising administering an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of the individual's skin at a depth of between about 100 and about 700 microns from the surface of the skin.

Abstract: The present invention relates to methods of producing lyophilized pharmaceutical compositions comprising a high concentration of therapeutic protein or antibody prior to lyophilization, wherein the lyophilized formulation can be reconstituted with a diluent in about 15 minutes or less. The invention also relates to the high concentration lyophilized formulations produced by the methods described herein. The lyophilized formulations produced by the methods of the invention are stable and are suitable for veterinary and human medical use and are suitable for modes of administration including oral, pulmonary and parenteral, such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. Also provided by the invention are high concentration pharmaceutical compositions that have long term stability and can be reconstituted, following lyophilization, in a short period of time, preferably 15 minutes or less.

Abstract: The present invention relates to a method of vaccinating a patient against varicella zoster virus (VZV) by delivery of an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of a patient's skin at a depth of between about 100 and about 700 microns from the surface of the skin, which is useful for preventing herpes zoster or reducing the severity or duration thereof. In embodiments of the invention, the patient is 50 years of age or older and has been previously exposed to VZV. The invention also relates to a method of preventing VZV infection in an individual who was not previously infected with VZV comprising administering an effective amount of a live attenuated VZV vaccine to the epidermis or the dermis of the individual's skin at a depth of between about 100 and about 700 microns from the surface of the skin.

Abstract: The present invention relates to pharmaceutical compositions comprising virus-like particles (VLPs) of HPV, said VLPs adsorbed to an aluminum adjuvant, and an ISCOM-type adjuvant comprising a saponin, cholesterol, and a phospholipid. In preferred embodiments, the aluminum adjuvant comprises amorphous aluminum hydroxyphosphate sulfate. Another aspect of the invention provides multi-dose HPV vaccine formulations comprising HPV VLPs and an antimicrobial preservative selected from the group consisting of: m-cresol, phenol and benzyl alcohol. Also provided are methods of using the disclosed pharmaceutical compositions and formulations to induce an immune response against HPV in a human patient and to prevent HPV infection.

Abstract: The present invention relates to methods of producing lyophilized pharmaceutical compositions comprising a high concentration of therapeutic protein or antibody prior to lyophilization, wherein the lyophilized formulation can be reconstituted with a diluent in about 15 minutes or less. The invention also relates to the high concentration lyophilized formulations produced by the methods described herein. The lyophilized formulations produced by the methods of the invention are stable and are suitable for veterinary and human medical use and are suitable for modes of administration including oral, pulmonary and parenteral, such as intravenous, intramuscular, intraperitoneal, or subcutaneous injection. Also provided by the invention are high concentration pharmaceutical compositions that have long term stability and can be reconstituted, following lyophilization, in a short period of time, preferably 15 minutes or less.

Abstract: Disclosed is a system or matrix approach for determining compatibility of a pharmaceutically active substance, such as small molecule drug candidate, therapeutic proteins, peptides, vaccines or RNAi, with materials used in the research and development of pharmaceuticals, including plastics, polymers, resins, rubbers, elastomers, glass and steel.

Abstract: The present invention relates to pharmaceutical compositions comprising virus-like particles (VLPs) of HPV, said VLPs adsorbed to an aluminum adjuvant, and an ISCOM-type adjuvant comprising a saponin, cholesterol, and a phospholipid. In preferred embodiments, the aluminum adjuvant comprises amorphous aluminum hydroxyphosphate sulfate. Another aspect of the invention provides multi-dose HPV vaccine formulations comprising HPV VLPs and an antimicrobial preservative selected from the group consisting of: m-cresol, phenol and benzyl alcohol. Also provided are methods of using the disclosed pharmaceutical compositions and formulations to induce an immune response against HPV in a human patient and to prevent HPV infection.

Abstract: The present invention relates to pharmaceutical compositions comprising virus-like particles (VLPs) of HPV, said VLPs adsorbed to an aluminum adjuvant, and an ISCOM-type adjuvant comprising a saponin, cholesterol, and a phospholipid. In preferred embodiments, the aluminum adjuvant comprises amorphous aluminum hydroxyphosphate sulfate. Another aspect of the invention provides multi-dose HPV vaccine formulations comprising HPV VLPs and an antimicrobial preservative selected from the group consisting of: m-cresol, phenol and benzyl alcohol. Also provided are methods of using the disclosed pharmaceutical compositions and formulations to induce an immune response against HPV in a human patient and to prevent HPV infection.