Minimizing Your Risk In RNA-Lipid Nanoparticle (LNP) Encapsulation And Drug Product Manufacturing Through A Holistic Approach

Developing and manufacturing lipid nanoparticle (LNP) drug products containing nucleic acid payloads presents significant process challenges, including maintaining stability, efficacy, and quality during encapsulation, transportation, freeze-thaw cycles, mixing, filtration, and filling.

Achieving successful GMP batch manufacturing with a "first-time right" approach requires a deep understanding of encapsulation and aseptic filling, as well as proactive risk mitigation prior to clinical material production.

Lonza has developed a platform-based strategy to assess critical steps like encapsulation and filtration, minimizing risks in these processes.

• Learn about Lonza's integrated drug substance/drug product offering for your IND program and beyond, with a holistic approach to ensure process robustness at every stage.
• Explore the challenge of developing and manufacturing LNPs with nucleic acids as payloads and discover Lonza's approach to overcoming them.
• Gain insights into key critical parameters, such as filter types and sizes, along with best practices to ensure a robust manufacturing process.