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Lipid nanoparticle (LNP) formulation development begins on a small scale and transitions to a standardized large-scale impingement mixing system once a promising formulation has been identified. A number of factors need to be considered when scaling up novel LNP systems, including flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. This technical note explores the many hurdles of LNP scale-up and what to consider to overcome them.
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