Minimizing your risk in RNA-Lipid Nanoparticle (LNP) encapsulation and drug product manufacturing through a holistic end-to-end approach​

Ensuring the stability, efficacy, and quality of LNP drug product formulations containing nucleic acids as payloads has presented unique challenges in development and manufacturing. These include critical process steps such as encapsulation, transportation, freeze-thaw handling, mixing, filtration, and filling.

To achieve successful GMP batch manufacturing with a "first-time right" approach, it was essential to develop a deep understanding of the encapsulation process and aseptic filling operations, along with the ability to proactively mitigate risks ahead of GMP clinical material production.

To address these challenges, we developed a strategy focused on assessing key process steps—such as encapsulation and filtration—and implementing a platform-based approach to minimize associated risks.

Key Learning Objectives

• Learn about our 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 challenges of developing and manufacturing LNPs with nucleic acids as payloads and discover our 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.