Figure 1 | Scientific Reports

Figure 1

From: DoE-derived continuous and robust process for manufacturing of pharmaceutical-grade wide-range LNPs for RNA-vaccine/drug delivery

Figure 1The alternative text for this image may have been generated using AI.

Schematics of the developed process and comparison with existing method. (a) LNP is formed using a simple T-mixer serviced by flow-controlled syringe pumps. The process flow is indicated by arrow; dotted arrow indicates zoom view of the LNP size. (b) The DoE model and result of the DoE experiments revealed that in a sonication field the size of the LNPs gradually increased with the growing time and pH. Desired size of LNP can be achieved by selecting specific ‘operation space’ (dotted oval). (c) Single step buffer exchange is associated with the gradual size enlargement of LNP (top) but a 2-stage buffer exchange restricts LNP size (bottom). (d) Process development decision tree. (e) Different level of sonication power produced different level of effect on size enlargement of LNP. (f) A schematic diagram of relative position of the flow-path of fluid in sonication field of a water bath sonicator. (g) Process flow for small volume (1 ml and 10 ml) batches. (h) Process flow for large batch in continuous mode.

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