Systems and methods for manufacturing lipid nanoparticles and liposomes
Inventors
Barbosa, Christopher J. • MOLESCHI, Kody • CRETNEY, David
Assignees
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Publication Number
US-12329857-B2
Publication Date
2025-06-17
Expiration Date
Abstract
Systems including specific arrangements of pumps, valves, and conduits, such as for mixing precursors to lipid nanoparticles to form the lipid nanoparticles, are provided. Methods of using such systems to manufacture the lipid nanoparticles are also provided.
Core Innovation
The disclosure describes cationic lipid structures, including compounds of Formula (X), Formula (XI), Formula (III), Formula (IV), Formula (V), Formula (VI), and Formula (IX), with variable substituent groups, linker groups, bridging groups, and headgroup motifs. Representative structural embodiments include XIA–XID, XI-1 through XI-10, Formula (Ia), Formula (Ib), Formula (Ic), VIA, VIB, IXA through IXD, and IX-1 to IX-14, illustrating permitted structural arrangements within the stated formula frameworks.
The patent content also provides defined substituent groups and constraints for variables such as X, Y, L1, L2, L3, L, Z, Q, E, G1, G2, G3, R, R1, R2, R3, R4, R5, R6, R7, R8, Rx, a, b, c, d, e, f, g, h, n, x, and related indices. The disclosure includes allowed functional-group patterns, integer ranges, and example substructures, and it presents representative chemical structures in tables and figures to illustrate the described cationic lipid compositions.
The provided claim content further describes a system and method for manufacturing lipid nanoparticles using an organic lipid stock solution and an aqueous nucleic acid stock solution. The system includes first and second reservoirs, pumps, a multiport switching valve with first and second operating positions, and a mixing assembly with first and second inlets and a mixing assembly outlet; the method includes pumping the stock solutions to valve inlet ports, switching the valve operating positions, mixing within the mixing assembly to create a first mixture, and flowing the first mixture out through the mixing assembly outlet.
Claims Coverage
The consolidated claim coverage includes two independent claims directed to a valve-controlled lipid nanoparticle mixing system and a corresponding manufacturing method. The inventive features center on selective fluidic routing of an organic lipid stock solution and an aqueous nucleic acid stock solution through a multi-port, two-position valve to separate mixing assembly inlets, with defined reservoir return couplings across valve operating positions.
Two-stock valve-controlled mixing system
A system comprising a first reservoir containing an organic lipid stock solution, a second reservoir containing an aqueous nucleic acid stock solution, first and second pumps coupled to the reservoirs, a valve with multiple inlet and outlet ports, and a mixing assembly with first and second inlet ports coupled to valve outlet ports and a mixing assembly outlet.
Valve operating positions for selective routing to mixing assembly inlets
The valve has a first operating position in which the first valve inlet port is fluidically coupled to the first valve outlet port and the second valve inlet port is fluidically coupled to the second valve outlet port, and a second operating position in which those couplings are not made; the first and second valve outlet ports are fluidically coupled to corresponding mixing assembly inlets.
Reservoir coupling maintained across both valve positions
The third valve outlet port is fluidically coupled to the first reservoir in both operating positions, and the fourth valve outlet port is fluidically coupled to the second reservoir in both operating positions.
Valve-switching method for lipid nanoparticle manufacture
A method of manufacturing lipid nanoparticles comprising providing the organic lipid stock solution and aqueous nucleic acid stock solution in respective reservoirs, pumping each stock solution to corresponding valve inlet ports, operating the valve in a second operating position in which the inlet ports are not fluidically connected to the mixing assembly inlets, then switching to a first operating position to flow both stock solutions to the mixing assembly inlets, mix within the mixing assembly to create a first mixture, and flow the first mixture out through the mixing assembly outlet.
Overall, the claims cover a multi-port valve routing architecture and a switching method that control whether the stock solutions enter the mixing assembly together to create a first mixture for lipid nanoparticle manufacture, while maintaining defined reservoir couplings through the valve.
Stated Advantages
Reducing startup material waste and time lost during priming/equilibration.
Documented Applications
Manufacturing lipid nanoparticles for nucleic-acid payloads, including nucleic acids such as mRNA.
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