Processes for preparing lipid nanoparticles
AssigneeModernaTX, Inc.
InventorsChang TIAN, Michael H. SMITH, Benjamin GELDHOF
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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.
Claims23
A process for preparing lipid nanoparticles (LNPs), comprising mixing a lipid solution with an aqueous buffer solution in a T-Mixer, thereby forming a lipid nanoparticle solution (LNP solution) comprising LNPs, wherein:
- the lipid solution is fed to a lipid inlet of the T-Mixer at a lipid inlet back pressure of about 60 psi or less;
- the aqueous buffer solution is fed to a buffer inlet of the T-Mixer at a buffer inlet back pressure of about 60 psi or less;
- the LNP solution exits the LNP outlet of the T-Mixer at a flow rate of about 500 mL/min or greater;
- and
- the LNPs have an average diameter of about 100 nm or less.
Dependencies are inferred from the claim text.