Abstract: Provided herein are methods and compositions of a surrogate mRNA drug product. The surrogate mRNA drug product is made up of a physical property surrogate, a visual property surrogate, and a chemical property surrogate. The surrogate mRNA drug product has at least one quantitative or qualitative property such as viscosity, turbidity, density, and surface tension that is comparable to and matches the same property of a mRNA drug product comprised of mRNA in a lipid nanoparticle (LNP). The surrogate mRNA drug product, however, does not comprise mRNA or LNP.

Abstract: The present disclosure provides processes for controlled high-throughput preparation of lipid nanoparticle with defined parameters. A cross mixer can include a central region, a first inlet in fluidic communication with the central region, a second inlet in fluidic communication with the central region, a third inlet in fluidic communication with the central region, and an outlet in fluidic communication with the central region, the outlet oriented at an angle of between about 35° and about 120° from the first inlet and an angle of between about 35° and about 120° from the second inlet.

Abstract: The present disclosure provides processes for controlled high-throughput preparation of lipid nanoparticle with defined parameters, e.g., processes for preparing lipid nanoparticles (LNPs), using a T-Mixer (e.g., a T-Mixer as described herein). The present disclosure also provides lipid nanoparticle solutions (LNP solutions) and lipid nanoparticles (LNPs) being prepared by the processes.

Abstract: Provided are lipid nanoparticle compositions, and processes for their preparation, which are useful for the delivery of therapeutic or prophylactic agents to airway epithelium in patients.

Abstract: Provided are empty lipid nanoparticle compositions, and processes for their preparation, which are useful in the preparation of therapeutic or prophylactic lipid nanoparticle compositions comprising a therapeutic or prophylactic agent including, for example, nucleic acids such as mRNA.

Abstract: The disclosure features novel methods of producing nucleic acid lipid nanoparticle (LNP) compositions employing a modifying agent after formation of a precursor nucleic acid lipid nanoparticle, the produced compositions thereof, and methods involving the nucleic acid lipid nanoparticles useful in the delivery of therapeutics and/or prophylactics, such as a nucleic acid, to mammalian cells or organs to, for example, to regulate polypeptide, protein, or gene expression.

Abstract: This disclosure provides improved lipid-based compositions, including lipid nanoparticle compositions, and methods of use thereof for delivering agents in vivo including nucleic acids and proteins.

Abstract: This disclosure provides improved lipid-based compositions, including lipid nanoparticle compositions, and methods of use thereof for delivering agents in vivo including nucleic acids and proteins.

Abstract: The present disclosure provides methods of producing lipid nanoparticle (LNP) formulations and LNP formulations produced by using such methods. The present disclosure further provides therapeutic and diagnostic uses related to the produced LNP formulations.

Abstract: The present disclosure provides methods of producing lipid nanoparticle (LNP) formulations and the produced LNP formulations thereof. The present disclosure also provides therapeutic and diagnostic uses related to the produced LNP formulations.

Abstract: Methods for preparing particles and related compositions are provided. In some embodiments, the particles include at least one polynucleotide (e.g., mRNA), and in certain embodiments, the particles may include at least one ionizable molecule (e.g., a lipid). A method for preparing a suspension including the particles may comprise one or more filtration steps. In some such embodiments, prior to or during filtration, one or more properties of the particles (e.g., surface charge) and/or one or more properties of the suspension (e.g., pH) may be altered. In some embodiments, altering one or more properties of the particles and/or suspension may improve yield, improve a characteristic of the resulting composition, and/or prevent or reduce certain problems, such as fouling during the filtration process.

Abstract: Methods for preparing particles and related compositions are provided. In some embodiments, the particles include at least one polynucleotide (e.g., mRNA), and in certain embodiments, the particles may include at least one ionizable molecule (e.g., a lipid). A method for preparing a suspension including the particles may comprise one or more filtration steps. In some such embodiments, prior to or during filtration, one or more properties of the particles (e.g., surface charge) and/or one or more properties of the suspension (e.g., pH) may be altered. In some embodiments, altering one or more properties of the particles and/or suspension may improve yield, improve a characteristic of the resulting composition, and/or prevent or reduce certain problems, such as fouling during the filtration process.

Abstract: A hydro fire mitigation system is provided that is associated with a structure. The system employs a number of sensors that detect an oncoming fire, which directs a controller to initiate fluid flow through a number of sprinklers. The system is fully autonomous and does not require municipal water or power during use.

Abstract: This disclosure provides improved lipid-based compositions, including lipid nanoparticle compositions, and methods of use thereof for delivering agents in vivo including nucleic acids and proteins.

Abstract: Some embodiments of a build of material production system have been presented. In one embodiment, a graphical user interface (GUI) is presented via a client machine on factory floor to allow a user to submit a request to build a document from a master document in a predetermined natural language and a predetermined format. Further, a visual representation of a current build status of the document is provided in the GUI.

Abstract: A hydro fire mitigation system is provided that is associated with a structure. The system employs a number of sensors that detect an oncoming fire, which directs a controller to initiate fluid flow through a number of sprinklers. The system is fully autonomous and does not require municipal water or power during use.

Abstract: Methods for preparing particles and related compositions are provided. In some embodiments, the particles include at least one polynucleotide (e.g., mRNA), and in certain embodiments, the particles may include at least one ionizable molecule (e.g., a lipid). A method for preparing a suspension including the particles may comprise one or more filtration steps. In some such embodiments, prior to or during filtration, one or more properties of the particles (e.g., surface charge) and/or one or more properties of the suspension (e.g., pH) may be altered. In some embodiments, altering one or more properties of the particles and/or suspension may improve yield, improve a characteristic of the resulting composition, and/or prevent or reduce certain problems, such as fouling during the filtration process.

Abstract: A hydro fire mitigation system is provided that is associated with a structure. The system employs a number of sensors that detect an oncoming fire, which directs a controller to initiate fluid flow through a number of sprinklers. The system is fully autonomous and does not require municipal water or power during use.

Abstract: A hydro fire mitigation system is provided that is associated with a structure. The system employs a number of sensors that detect an oncoming fire, which directs a controller to initiate fluid flow through a number of sprinklers. The system is fully autonomous and does not require municipal water or power during use.

Abstract: Some embodiments of a publishing tool to translate documents have been presented. In one embodiment, a master document written in a first natural language is received. The master document is repurposed to generate a set of output documents in one or more predetermined formats, wherein each of the output document is in a distinct one of a set of natural languages.