Abstract: This disclosure relates to the field of RNA to prevent or treat multiple infectious agents. In particular, the present disclosure relates to methods and agents for vaccination against coronavirus infection, influenza infection, and/or RSV infection and inducing effective coronavirus, influenza virus, and/or RSV antigen-specific immune responses such as antibody and/or T cell responses. Specifically, in one embodiment, the present disclosure relates to methods comprising administering to a subject (i) a bivalent RNA vaccine encoding peptides or proteins comprising epitopes of SARS-CoV-2 spike proteins (S proteins) and (ii) a tetravalent RNA vaccine encoding peptides or proteins comprising epitopes of hemagglutinin (HA), for inducing an immune response against coronavirus S proteins, in particular S proteins of SARS-CoV-2, and influenza proteins, in particular HA proteins of type A and type B influenza viruses, in the subject.

Abstract: The invention relates to the lyophilization of a liquid pharmaceutical formulation including lipid nanoparticles encapsulating mRNA. According to the invention, a spray freeze-drying process is used to achieve the lyophilization. The invention is of particular interest for the lyophilization of mRNA vaccine formulations.

Abstract: The invention relates to a coaxial flow device 1 capable of creating comparable microenvironments at various operation scales through the continuous introduction and mixing of nanoparticle precursor solutions for the manufacturing of a dispersion comprising nanoparticles. According to the invention, the device includes first and second coaxial tubes 3, 5 for controlled flows of nanoparticle precursor solutions and a mixing portion 7, wherein a disrupting physical element 21 is arranged to cause formation of the microenvironments. Application to the production of mRNA vaccines.

Abstract: This invention provides methods for producing homogeneous and heterogeneous adjuvant formulations comprising a liposome bilayer comprising (a) monophosphoryl lipid A (MPLA), (b) a saponin, and (c) a liposome composition comprising (i) at least one phospholipid selected from phosphatidylcholine (PC) and/or phosphatidylglycerol (PG), wherein the phospholipid is selected from the group consisting of dimyristoyl phosphatidylcholine (DMPC), dipalmitoyl phosphatidylcholine (DPPC), distearyl phosphatidylcholine (DSPC), dimyristoyl phosphatidylglycerol (DMPG), dipalmitoyl phosphatidylglycerol (DPPG), distearyl phosphatidylglycerol (DSPG), and a combination thereof, and (ii) cholesterol wherein the mole percent concentration of the cholesterol in the liposome composition is greater than 50% (mol/mol), and further provides the adjuvant formulations produced from said methods.

Abstract: The present disclosure relates to compositions comprising RNA molecules encoding an antigen derived from influenza, wherein the RNA may be formulated in a lipid nanoparticle (LNP), and wherein the composition further includes a polypeptide antigen derived from respiratory syncytial virus (RSV) and/or RNA molecules encoding an antigen derived from RSV, wherein the RSV RNA may be may be formulated in an LNP. The present disclosure further relates to the use of the RNA molecules, RNA-LNPs and compositions for the prevention of influenza and RSV infection-induced illness.

Abstract: The present disclosure provides technologies relating to stabilization of lipid nanoparticle mRNA compositions (e.g., vaccines).

Abstract: The present disclosure relates to the fields of packaging, transportation, and storage of temperature-sensitive materials, such as biological and/or pharmaceutical products. Various aspects of such packaging, transportation, and storage are provided herein for ultra-low temperature materials useful for the treatment and/or prevention of disease. The present disclosure also provides packaging materials, methods of transportation, and methods of storage for maintaining biological and/or pharmaceutical materials at ultra-low temperatures in order to maintain the integrity of the materials. The present disclosure further relates to the field of RNA to prevent or treat coronavirus infection.

Abstract: The present disclosure relates generally to the field of lipid nanoparticle (LNP) compositions comprising RNA, methods for preparing and storing such compositions, and the use of such compositions in therapy.

Abstract: This invention relates to enhanced stabilization and improved lyophilization methods of pharmaceutical substances.

Abstract: The invention relates to compositions and methods for the preparation, manufacture and therapeutic use ribonucleic acid vaccines comprising polynucleotide molecules encoding one or more influenza antigens, such as hemagglutinin antigens.

Abstract: Materials and Methods are provided for producing patterned multi-array, multi-specific surfaces for use in diagnostics. The invention provides for electrochemiluminescence methods for detecting or measuring an analyte of interest. It also provides for novel electrodes for ECL assays. Materials and methods are provided for the chemical and/or physical control of conducting domains and reagent deposition for use multiply specific testing procedures.

Abstract: Materials and methods are provided for producing patterned multi-array, multi-specific surfaces for use in diagnostics. The invention provides for electrochemiluminescence methods for detecting or measuring an analyte of interest. It also provides for novel electrodes for ECL assays. Materials and methods are provided for the chemical and/or physical control of conducting domains and reagent deposition for use multiply specific testing procedures.

Abstract: A method for processing multi-phasic dispersions is provided. The method comprises providing a multi-phasic dispersion including dispersed and continuous phases, providing one or more non-solvents comprising an aqueous solution containing at least one multivalent cation, exposing the multi-phasic dispersion to the non-solvent to form a suspension containing one or more liquid phases and the solid microparticles, and removing at least a portion of the resulting one or more liquid phases while retaining at least the microparticles, thereby removing at least a portion of the non-volatile material from the microparticles.

Abstract: Materials and methods are provided for producing patterned multi-array, multi-specific surfaces for use in diagnostics. The invention provides for electrochemiluminescence methods for detecting or measuring an analyte of interest. It also provides for novel electrodes for ECL assays. Materials and methods are provided for the chemical and/or physical control of conducting domains and reagent deposition for use multiply specific testing procedures.

Abstract: Materials and methods are provided for producing patterned multi-array, multi-specific surfaces for use in diagnostics. The invention provides for electrochemiluminescence methods for detecting or measuring an analyte of interest. It also provides for novel electrodes for ECL assays. Materials and methods are provided for the chemical and/or physical control of conducting domains and reagent deposition for use multiply specific testing procedures.

Abstract: A method for processing multi-phasic dispersions is provided. The method comprises providing a multi-phasic dispersion including dispersed and continuous phases, providing one or more non-solvents comprising an aqueous solution containing at least one multivalent cation, exposing the multi-phasic dispersion to the non-solvent to form a suspension containing one or more liquid phases and the solid microparticles, and removing at least a portion of the resulting one or more liquid phases while retaining at least the microparticles, thereby removing at least a portion of the non-volatile material from the microparticles.

Abstract: The present disclosure is directed to surface-modified microparticles, pharmaceutical compositions thereof, and methods of making and using such particles. The surface-modified microparticles include a microparticle core, and at least one monolayer associated with the microparticle core. The monolayer comprises an amphiphilic polymer or non-ionic polymer grafted to an ionic polymer.

Abstract: An encapsulated particle, comprising a plurality of preformed microparticles encapsulated in an amorphous matrix, wherein at least one of the preformed microparticles comprises a core microparticle and a monolayer associated with the outer surface of the core microparticle. The core microparticle comprises at least one active agent that is capable of being released from the encapsulated particle.

Abstract: Materials and methods are provided for producing patterned multi-array, multi-specific surfaces for use in diagnostics. The invention provides for electrochemiluminescence methods for detecting or measuring an analyte of interest. It also provides for novel electrodes for ECL assays. Materials and methods are provided for the chemical and/or physical control of conducting domains and reagent deposition for use multiply specific testing procedures.

Abstract: Materials and methods are provided for producing patterned multi-array, multi-specific surfaces for use in diagnostics. The invention provides for electrochemiluminescence methods for detecting or measuring an analyte of interest. It also provides for novel electrodes for ECL assays. Materials and methods are provided for the chemical and/or physical control of conducting domains and reagent deposition for use multiply specific testing procedures.