Physicochemical and biological evaluation of a GMP‑grade ionizable lipid for robust and scalable manufacturing of siRNA- and mRNA-loaded lipid nanoparticles.
The clinical translation of RNA-loaded lipid nanoparticles (LNPs) requires GMP-grade excipients supported by a rigorous analytical control strategy. This study aimed to evaluate the GMP-grade ionizable lipid (YCE-C10) as a manufacturing-ready component for siRNA- and mRNA-loaded LNPs produced by scalable microfluidic m...