Abstract: The disclosure features a lipid nanoparticle (LNP) formulation comprising a plurality of LNPs and a stabilizing agent that mitigates the degradation of the LNPs or a subpopulation thereof. Lipid nanoparticles further including therapeutics and/or prophylactics such as RNA are useful in the delivery of therapeutics and/or prophylactics to mammalian cells or organs to, for example, regulate polypeptide, protein, or gene expression. Methods of manufacturing LNP formulations and screening for a stabilizing agent are also disclosed.

Abstract: The present invention provides formulations comprising a Factor IX—FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.

Abstract: Formulations of lipids and nucleic acids, including lipid nanoparticle formulations which encapsulate nucleic acids, stabilized with phenothiazinium dyes. In particular, the stabilization of LNP-mRNA formulations with methylene blue, Azure A, Azure B, Safranin O, phenosafranin or leucomethylene blue. Methods of making and of use of the formulations stabilized by chemical compounds are also provided.

Abstract: The present invention provides formulations comprising a Factor IX-FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.

Abstract: The disclosure features a lipid nanoparticle (LNP) formulation comprising a plurality of LNPs and a stabilizing agent that mitigates the degradation of the LNPs or a subpopulation thereof. Lipid nanoparticles further including therapeutics and/or prophylactics such as RNA are useful in the delivery of therapeutics and/or prophylactics to mammalian cells or organs to, for example, regulate polypeptide, protein, or gene expression. Methods of manufacturing LNP formulations and screening for a stabilizing agent are also disclosed.

Abstract: The present invention provides methods of administering long-acting Factor IX; methods of administering long-acting, chimeric and hybrid polypeptides comprising Factor IX; and methods of producing such chimeric and hybrid polypeptides using cells.

Abstract: The present invention provides methods of administering long-acting Factor IX; methods of administering long-acting, chimeric and hybrid polypeptides comprising Factor IX; and methods of producing such chimeric and hybrid polypeptides using cells.

Abstract: The present invention provides methods of administering long-acting Factor IX; methods of administering long-acting, chimeric and hybrid polypeptides comprising Factor IX; and methods of producing such chimeric and hybrid polypeptides using cells.

Abstract: The present invention provides formulations comprising a Factor IX-FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.

Abstract: The present invention provides formulations comprising a Factor IX-FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.

Abstract: The disclosure features a lipid nanoparticle (LNP) formulation comprising a plurality of LNPs and a stabilizing agent that mitigates the degradation of the LNPs or a subpopulation thereof. Lipid nanoparticles further including therapeutics and/or prophylactics such as RNA are useful in the delivery of therapeutics and/or prophylactics to mammalian cells or organs to, for example, regulate polypeptide, protein, or gene expression. Methods of manufacturing LNP formulations and screening for a stabilizing agent are also disclosed.

Abstract: The present invention relates to a dry transglutaminase composition, said composition is obtainable by lyophilizing or spray-drying an aqueous composition comprising a transglutaminase, a salt and at least one further component selected from the group consisting of a sugar, an amino acid, and a buffer, wherein the concentration of the salt in the aqueous composition is in the range from 5 to 100 mM. In further aspects, the present invention relates to a method of preparing said dry transglutaminase composition, a reconstituted solution, a pharmaceutical composition, and method of treatments.

Abstract: The present invention provides formulations comprising a Factor IX-FcRn Binding Partner (FIXFBP) polypeptide, and methods of administering FIXFBP.

Abstract: The present invention provides methods of administering long-acting Factor IX; methods of administering long-acting, chimeric and hybrid polypeptides comprising Factor IX; and methods of producing such chimeric and hybrid polypeptides using cells.

Abstract: Stable preserved compositions of interferon-? and pegylated-interferon-? are described.

Abstract: The present invention relates to a dry transglutaminase composition, said composition is obtainable by lyophilizing or spray-drying an aqueous composition comprising a transglutaminase, a salt and at least one further component selected from the group consisting of a sugar, an amino acid, and a buffer, wherein the concentration of the salt in the aqueous composition is in the range from 5 to 100 mM. In further aspects, the present invention relates to a method of preparing said dry transglutaminase composition, a reconstituted solution, a pharmaceutical composition, and method of treatments.

Abstract: The present invention relates to insulin crystals formed from zinc, protamine, a hexamer-stabilizing compound, and a polypeptide selected from the group consisting of insulin, an insulin analog, and a derivatized insulin. The crystals are suitable for administering to a patient for control of blood glucose levels. The crystals have been derived from the neutral protamine Hagedorn (NPH) form in a process utilizing precisely determined protamine concentrations and fortification of NPH crystals formed at a first lower concentration of protamine to achieve a second higher concentration of protamine.

Abstract: The present invention relates to a process for forming non-adsorbed insulin crystals from zinc, protamine, a hexamer-stabilizing compound, and a polypeptide selected from the group consisting of insulin, an insulin analog, a derivatized insulin, and a derivatized insulin analog. The crystals are suitable for administering to a patient for control of blood glucose levels. The crystals are formed in a process utilizing precisely determined protamine concentrations.