mRNA Drug Substance Journey To LNP Drug Product: Scale-Up Via Microfluidic Mixing

By Matthew Kingland, Jacob Campbell Ph.D., Jenna Sjoerdsma Ph.D., Brandon Demuth, Samuel Vinje, Aldevron

Messenger RNA (mRNA) has emerged as a promising therapeutic modality, but fragmented expertise across the manufacturing process presents a significant challenge. Traditionally, clinical-grade mRNA production may necessitate multiple Contract Development and Manufacturing Organizations (CDMOs). This study describes a novel platform designed to streamline mRNA drug development.

Aldevron, a leading CDMO, established a program for the production of high-quality mRNA drug substance. To address the challenge of lipid nanoparticle (LNP) drug product formulation, Aldevron partnered with Precision NanoSystems, leveraging their NxGenTM microfluidic mixing technology. Utilizing this platform, Aldevron successfully formulated and scaled up LNPs encapsulating the mRNA construct DasherGFP®. Data confirms the production of high-quality LNP formulations and a scalable process suitable for GMP-compliant Phase I and II clinical trials.

Building upon its extensive experience as a critical raw material supplier for plasmid and mRNA drug substance, Aldevron's platform represents a natural extension of its capabilities. This strategy, supported by a commitment to quality, advanced facilities, and a skilled workforce, positions Aldevron to effectively support clients throughout the entire mRNA therapeutic development process.