Lipid nanoparticles (LNPs) have emerged as the leading delivery platform for mRNA therapeutics, offering protection and efficient cellular uptake of fragile RNA molecules. However, the path from lab-scale formulation to commercial-scale manufacturing presents a host of challenges that require deep technical insight and cross-functional coordination.
This presentation will explore the end-to-end manufacturing process for mRNA-LNP drug products with discussion on material considerations and common challenges encountered with LNP manufactures such as filtration. Emphasis will be placed on the critical quality attributes (CQAs) of LNPs, including particle size, encapsulation efficiency, and RNA integrity and how these are influenced by raw material variability and process parameters.
Innovations in manufacturing will be highlighted to enable scalable, robust, and GMP-compliant LNP production. The session will also address regulatory expectations, analytical testing strategies for novel excipients, and lessons learned from accelerated vaccine development during the COVID-19 pandemic.
Learning Objectives:
Understand the core steps and control strategies in the manufacturing of mRNA-LNP drug products.
Identify key material considerations, including lipid sourcing, impurity control, and analytical testing requirements.
Recognize process challenges such as shear sensitivity, filtration, and scale-up.
