Custom Lipids: Navigating Synthesis Complexity, Ensuring Quality, and Meeting Regulatory Compliance

WEBINAR

As the demand for tailored lipids grows, the complexity of their development and synthesis has increased significantly. This session will provide insights into the challenges of creating high-quality custom lipids essential for lipid nanoparticles (LNPs) in clinical applications.

We will focus on the expertise needed for successful lipid development and the importance of early planning to enable smooth scale-up to GMP standards. Participants will learn how lipid quality influences the performance and safety of LNPs, vital e.g. for mRNA vaccines and gene therapies. Additionally, participants will gain insights into how navigating the regulatory landscape effectively can streamline the path to clinical trials and market entry, ensuring that innovative therapies meet the necessary requirements.

In this webinar, you will learn:

• the complexities of developing high quality custom lipids and the critical parameters required for successful scale-up to GMP manufacturing
• the regulatory landscape and requirements for lipid development and drug products, focusing on pathways to successful clinical phases and commercial manufacturing