Abstract: A method of manufacturing an immunogenic composition forming a vaccine is disclosed. The method includes providing an antigen, providing a dry lipid blend, hydrating the dry lipid blend with an antigen solution, wherein the hydration is configured to form a colloidal vaccine solution, and extruding the colloidal vaccine solution, wherein the extrusion is configured to form a vaccine particle.

Abstract: An immunogenic composition forming a vaccine includes a nanoparticle delivery system comprising at least a nanoparticle, wherein the at least a nanoparticle comprises a lipid layer exterior including a plurality of lipids, cholesterol, and a primary alkyl amine including a positively charged amino group head and at least a carbon tail and an antigen incorporated in the at least a nanoparticle, wherein the antigen comprises a nucleic acid encoding a protein from a coronavirus.

Abstract: A method of manufacturing an immunogenic composition forming a vaccine, the method including providing a dried nanoparticle adjuvant, wherein the nanoparticle adjuvant includes a plurality of nanoparticles, and each nanoparticle comprises a lipid layer exterior including a plurality of lipids, cholesterol, and a primary alkyl amine including an amino group head and at least a carbon tail, providing a dried antigen, combining the dried antigen with the dried nanoparticle adjuvant, and reconstituting the combined dried antigen and dried nanoparticle adjuvant.

Abstract: An immunogenic composition forming a vaccine includes a nanoparticle adjuvant comprising at least a nanoparticle, wherein the at least a nanoparticle comprises a lipid layer exterior including a plurality of lipids, cholesterol, and a primary alkyl amine including a positively charged amino group head and at least a carbon tail and an antigen incorporated in the at least a nanoparticle, wherein the antigen comprises a spike protein from a coronavirus.

Abstract: An immunogenic composition forming a vaccine includes a nanoparticle adjuvant comprising at least a nanoparticle, wherein the at least a nanoparticle comprises a lipid layer exterior including a plurality of lipids, cholesterol, and a primary alkyl amine including a positively charged amino group head and at least a carbon tail and an antigen incorporated in the at least a nanoparticle, wherein the antigen comprises a spike protein from a coronavirus.

Abstract: An immunogenic composition forming a vaccine includes a nanoparticle delivery system comprising at least a nanoparticle, wherein the at least a nanoparticle comprises a lipid layer exterior including a plurality of lipids, cholesterol, and a primary alkyl amine including a positively charged amino group head and at least a carbon tail and an antigen incorporated in the at least a nanoparticle, wherein the antigen comprises a nucleic acid encoding a protein from a coronavirus.

Abstract: The present invention provides a novel albumin-free preparation of Factor VIII has a high amount of salt and a low concentration of sugar and of glycine. The high salt provides stability and an elegant cake structure as the major crystalline component. The sugar and glycine provide a complex amorphous matrix together with some amorphous non-crystallized salt for stabilization of Factor VIII. This formulation is suitable for B-domain deleted Factor VIII that requires a high ionic strength environment for stability. The addition of low amount of glycine to the sucrose prevents the crystallization of salt. This results in an amorphous matrix comprising of glycine, sucrose, and salt. This amorphous matrix provides a stabilizing environment where Factor VIII is protected by three stabilizers; amino acid (glycine), sugar (sucrose or trehalose), and salt (NaCl). Such an amorphous matrix that can stabilize the Factor VIII across lyophilization and during storage as a lyophile.

Abstract: The present invention provides a novel albumin-free formulation of recombinant Factor VIII that does not require calcium ions as an added formulation excipient. The absence of calcium chloride in the formulation results in a number of improvements and benefits for a Factor VIII formulation. This invention allows a Factor VIII formulation that can be lyophilized more efficiently as the absence of calcium ions will increase primary glass transition of the amorphous phase. The absence of free calcium ions in the formulation will also improve the stability of the formulation as metal-dependent oxidation reactions will be avoided and the protein molecule will not be subjected to chemical instabilities. Finally, the absence of calcium will further simplify the Factor VIII formulation by reducing the number of excipients in the formulation.

Abstract: A vaccine adjuvant composition comprising: a lipid selected from the group consisting of: dipalmitoyl phosphatidlcholine (DPPC), dipalmitoyl phosphatidylglycerol (DPPG), dioleoyl phosphatidylcholine (DOPC), and cholesterol and containing a positively or negatively charged lipid with associated/entrapped protein antigen.

Abstract: The present invention provides a novel albumin-free formulation of recombinant Factor VIII that does not require calcium ions as an added formulation excipient. The absence of calcium chloride in the formulation results in a number of improvements and benefits for a Factor VIII formulation. This invention allows a Factor VIII formulation that can be lyophilized more efficiently as the absence of calcium ions will increase primary glass transition of the amorphous phase. The absence of free calcium ions in the formulation will also improve the stability of the formulation as metal-dependent oxidation reactions will be avoided and the protein molecule will not be subjected to chemical instabilities. Finally, the absence of calcium will further simplify the Factor VIII formulation by reducing the number of excipients in the formulation.

Abstract: The present invention provides a novel albumin-free preparation of Factor VIII has a high amount of salt and a low concentration of sugar and of glycine. The high salt provides stability and an elegant cake structure as the major crystalline component. The sugar and glycine provide a complex amorphous matrix together with some amorphous non-crystallized salt for stabilization of Factor VIII. This formulation is suitable for B-domain deleted Factor VIII that requires a high ionic strength environment for stability. The addition of low amount of glycine to the sucrose prevents the crystallization of salt. This results in an amorphous matrix comprising of glycine, sucrose, and salt. This amorphous matrix provides a stabilizing environment where Factor VIII is protected by three stabilizers; amino acid (glycine), sugar (sucrose or trehalose), and salt (NaCl). Such an amorphous matrix that can stabilize the Factor VIII across lyophilization and during storage as a lyophile.

Abstract: A vaccine adjuvant composition comprising: a lipid selected from the group consisting of: dipalmitoyl phosphatidicholine (DPPC), dipalmitoyl phosphatidylglycerol (DPPG), dioleoyl phosphatidylcholine (DOPC), and cholesterol and containing a positively or negatively charged lipid with associated/entrapped protein antigen.

Abstract: A vaccine adjuvant composition comprising: a lipid selected from the group consisting of: Dipalmitoyl phosphatidlcholine (DPPC), Dipalmitoyl phosphatidylglycerol (DPPG), Dioleoyl phosphatidylcholine (DOPC), and cholesterol and containing a positively or negatively charged lipid with associated/entrapped protein antigen.

Abstract: System and methods provide formulation using pre-designed formulation plates for rapidly formulating proteins and peptides, wherein proteins are added to a plurality of wells in the plate; means for stressing one or more protein formulations; and means for analyzing samples of the protein formulations.

Abstract: Disclosed are compositions comprising a hydrophobic active agent, a polymer and a reconstitution enhancing agent. Reconstitution of the lyophilized form of the compositions takes less time than in the absence of the enhancing agent.

Abstract: A dry powder composition comprises recombinant human alpha 1-antitrypsin (rAAAT).

Abstract: Disclosed are compositions comprising a hydrophobic active agent, a polymer and a reconstitution enhancing agent. Reconstitution of the lyophilized form of the compositions takes less time than in the absence of the enhancing agent.

Abstract: Compositions for preparation of oral dosage forms for administration of proteins and polypeptides are described. The compositions include a species capable of stabilizing the protein or polypeptide such that it retains biological activity during storage, for activity upon administration in vivo.

Abstract: A stable pharmaceutical preparation comprising Human interleukin-2 or a variant thereof and a stabilizing amount of histidine. A preferred formulation includes glycine and sucrose and a variant of IL-2 having a single mutation, N88R. The preferred formulation is in lyophilized form which, on reconstitution with an aqueous diluent, results in a solution having a pH ranging from about 5.0 to 6.5.

Abstract: The present invention relates to pharmaceutical compositions for delivery of drugs intended to reside in the nose, compositions for nasal administration of drugs, e.g., antiviral agents, and particularly antiviral agents comprising the human major rhinovirus receptor, also known as intercellular adhesion molecule-1 (ICAM-1); to methods of making said nasal drug compositions, and to an improved process for the removal of residual solvent from pharmaceutical matrices.