Acceleration Strategies for mRNA-LNP Drug Development Focus on Shortening Early-Stage Process Development Timelines
- Our IVT platform, which includes initial IVT condition determination based on mRNA sequence information and optimization using DOE, enables the supply of GLP-Tox batch samples with dsRNA levels reduced to 0.02% or less within four months of PD initiation.
- Parameter optimization using high-throughput screening, which small amount of sample size and short period of time, and DOE enables GLP-Tox batch release within five months from the start of PD studies.
- Having multiscale manufacturing capability with full-scale development functionalities on a single site enables mRNA sequence design to LNP batch release in 12 months.