2nd mRNA & CGT: CMC, Process Development and Manufacturing

Speaker: Mojca Tajnik Sbaizero, Process Development Manager, Sartorius BIA Separations
Title: Enhancing Biopharmaceutical Production: Innovative Approaches for LNP-Based Therapies

Presentation abstract:

Lipid nanoparticle (LNP)-based biopharmaceuticals are revolutionizing nucleic acid delivery, yet they encounter challenges in manufacturing and characterization. Innovative solutions utilizing CIM (Convective Interaction Media) monolith chromatography enhance drug integrity, recovery rates, and characterization, including the entire process from plasmid DNA (pDNA) to RNA-LNP therapeutics. cGMP-compliant pDNA is processed and purified using monoliths, transcribed into mRNA, and further refined with a monolith toolbox before RNA encapsulation into LNPs. A groundbreaking purification method for LNPs replaces traditional techniques, significantly enhancing recovery, uniformity, and activity. PATfix platforms ensure rigorous quality monitoring and comprehensive characterization of payloads within LNPs.
The novel chromatographic process using CIM delivers superior activity and uniformity of RNA-LNP particles, guaranteeing consistent product quality and efficiency, thereby supporting the development of scalable, safe and effective LNP-based therapies, such as CAR-T, CRISPR, and vaccines.

Location: Vienna, Austria