Abstract: The present invention relates to thermally stable oral rotavirus vaccine formulations comprising one or more rotavirus reassortant or attenuated rotavirus strains, a pharmaceutically acceptable calcium salt, adipic acid, sucrose, and sodium phosphate, wherein each of the one or more rotavirus reassortant or attenuated rotavirus strain is stable for 7 days at 37° C., for 45 days at 25° C. and for 2 years or more at 2-8° C. The calcium containing formulations of the invention may further comprise one or more excipients which are present in an amount that is effective to optimize the calcium ions free in solution to stabilize the rotavirus particles. In embodiments of the invention, the formulation comprises a surfactant, such as polysorbate 80.

Abstract: Methods for improving the drying yield and stability of RSV vaccines comprising a highly thermolabile enveloped live virus and/or one or more RSV protein subunits, are described. Methods for rapid drying of RSV formulations containing between 17.5% and 60% w/w of a non-polymeric sugar and using either conduction or radiation dominant drying mechanisms, are disclosed. The disclosed methods provide for; 1) a dried RSV formulation with improved stability profile; 2) faster drying; and 3) integration of dried RSV into a primary device (such as dual chamber cartridges, foil-pouch devices etc.), pre- as well as post-drying.

Abstract: Methods for preparing lyophilized pellets of biological materials are described. The pellets have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a flat, solid surface, in particular, a surface that does not have any cavities, followed by lyophilizing the frozen droplets. These methods are useful for preparing lyophilized pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.

Abstract: The present invention relates to thermally stable oral rotavirus vaccine formulations comprising one or more rotavirus reassortant or attenuated rotavirus strains, a pharmaceutically acceptable calcium salt, adipic acid, sucrose, and sodium phosphate, wherein each of the one or more rotavirus reassortant or attenuated rotavirus strain is stable for 7 days at 37° C., for 45 days at 25° C. and for 2 years or more at 2-8° C. The calcium containing formulations of the invention may further comprise one or more excipients which are present in an amount that is effective to optimize the calcium ions free in solution to stabilize the rotavirus particles. In embodiments of the invention, the formulation comprises a surfactant, such as polysorbate 80.

Abstract: Methods for improving the drying yield and stability of RSV vaccines comprising a highly thermolabile enveloped live virus and/or one or more RSV protein subunits, are described. Methods for rapid drying of RSV formulations containing between 17.5% and 60% w/w of a non-polymeric sugar and using either conduction or radiation dominant drying mechanisms, are disclosed. The disclosed methods provide for; 1) a dried RSV formulation with improved stability profile; 2) faster drying; and 3) integration of dried RSV into a primary device (such as dual chamber cartridges, foil-pouch devices etc.), pre- as well as post-drying.

Abstract: Methods for preparing lyophilized pellets of biological materials are described. The pellets have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a flat, solid surface, in particular, a surface that does not have any cavities, followed by lyophilizing the frozen droplets. These methods are useful for preparing lyophilized pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.

Abstract: The invention relates to viral formulations and related pharmaceutical products for use in gene therapy and/or vaccine applications. Especially preferred viral formulations disclosed herein are liquid adenovirus formulations, which show improved stability when stored in about the 2-8° C. range while also being compatible with parenteral administration. These formulations comprise a buffer, a sugar, a salt, a divalent cation, a non-ionic detergent, as well as a free radical scavenger and/or a chelating agent to inhibit free radical oxidation.

Abstract: The invention relates to viral formulations and related pharmaceutical products for use in gene therapy and/or vaccine applications. Especially preferred viral formulations disclosed herein are liquid adenovirus formulations, which show improved stability when stored in about the 2-8° C. range while also being compatible with parenteral administration. These formulations comprise a buffer, a sugar, a salt, a divalent cation, a non-ionic detergent, as well as a free radical scavenger and/or a chelating agent to inhibit free radical oxidation.