The often overlooked later steps in making lipid nanoparticles

Downstream operations significantly influence critical quality attributes of lipid nanoparticles (LNPs).

• Downstream processing reshapes particle size, morphology, internal structure, payload distribution, and stability of LNPs.
• Each unit operation in downstream processing applies unique physical and chemical changes that affect the final drug product.
• The impact of downstream operations on product quality is dependent on the specific formulation used.
• Gaps exist in analytical technologies and mechanistic understanding that hinder LNP manufacturing.
• Effective LNP manufacturing may require a holistic approach that integrates both upstream and downstream processes.

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