Composition and method for spray drying an adjuvant vaccine emulsion
Inventors
Kramer, Ryan • ARCHER, Michelle • Fox, Christopher • Vehring, Reinhard • ORDOUBADI, Mani • GOMEZ, Mellissa • CARRIGY, Nicholas
Assignees
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Publication Number
US-12318436-B2
Publication Date
2025-06-03
Expiration Date
Abstract
The invention provides for thermostable spray dried formulations including vaccines and pharmaceutical compositions for inducing or enhancing an immune response and methods of use thereof. The spray dried formulations are a dry powder generally comprising an antigen and/or an adjuvant, a metabolizable oil, and one or more excipients.
Core Innovation
The invention provides thermostable spray-dried dry-powder vaccine compositions and therapeutics. The compositions include an oil-in-water emulsion containing an antigen and/or adjuvant, a metabolizable oil including squalene, trehalose, and an attenuated lipid A derivative (ALD), and are produced as dry powder by spray drying.
A key aspect is that the squalene is present in an oil-in-water emulsion that is liquid at room temperature. In embodiments, a shell-former forms gel-microparticles within the spray-dried powder, and the spray drying is performed at process parameters such that the outlet relative humidity is less than 10%.
The disclosure emphasizes preservation of component retention and nanoemulsion or gelling characteristics after spray drying and during accelerated stability storage. Documented proof-of-concept includes encapsulating squalene-based GLA-SE nanoemulsions with trehalose and Tris into amorphous microparticles while preserving nanoemulsion droplet size and component retention after spray drying and during 3-month accelerated stability up to 40°C.
The invention further targets pulmonary delivery performance, including pulmonary delivery refinement using leucine to improve aerosol performance and reported aerodynamic delivery metrics. Packaging arrangements are described to control humidity, including aluminum bags with desiccant and double heat-sealing.
Claims Coverage
The provided independent claims include two inventive concepts: a spray-dried dry-powder composition and a method of generating the thermostable dry powder by spray drying a defined oil-in-water emulsion in a spray dryer under process parameters.
AlD and squalene/trehalose gel-microparticle dry powder with constrained outlet humidity
A spray-dried composition in the form of a dry powder comprising an effective amount of an attenuated lipid A derivative (ALD), a gel-microparticle comprising squalene present in an oil-in-water emulsion that is liquid at room temperature and trehalose, having a particle size diameter less than about 120 μm, formed by spray drying with an outlet relative humidity of less than 10%.
Spray-drying defined antigen/qualene/trehalose/ALD/shell-former emulsion to obtain thermostable gel-microparticles
A method for generating a thermostable dry powder vaccine composition by spray drying, in a spray dryer using an atomization gas, an oil-in-water emulsion to obtain a dry powder at process parameters such that the dry powder comprises gel-microparticles, wherein the oil-in-water emulsion comprises an antigen, qualene, trehalose, an attenuated lipid A derivative (ALD), and a shell-former.
Across the independent claims, the inventive coverage is directed to thermostable spray-dried dry powder vaccines where an ALD-containing, trehalose-associated squalene or qualene oil-in-water emulsion is converted into gel-microparticles at constrained outlet relative humidity or by spray drying of a defined antigen/ALD/trehalose/shell-former emulsion in a spray dryer using an atomization gas.
Stated Advantages
Thermostable spray-dried dry-powder vaccine compositions
Formation of gel-microparticles with small particle size (less than about 120 μm)
Preservation of component retention and nanoemulsion or gelling characteristics after spray drying and during accelerated stability storage
Documented Applications
Pulmonary delivery using dry powder formulations with aerosol and aerodynamic performance measurements
Humidity-controlled packaging using aluminum bags with desiccant and double heat-sealing
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