Navigating GMP Manufacturing Workflows for RNA-LNP Therapeutics

Over the last few years, RNA-encapsulated lipid nanoparticles (RNA-LNPs) have emerged as a new drug modality with the potential to change the pace of biopharmaceutical innovation. GMP manufacturing of RNA-LNPs is both labor intensive and resource-heavy, requiring stringent protocols and environmental controls to ensure RNA integrity and consistency, as well as robust quality control and documentation. As RNA-LNPs mature and expand to new applications and diverse scales, the manufacturing process poses new challenges that biopharma companies must address to ensure that their workflows remain effective and productive.In this GEN webinar, David Sokolowski and Ingram Vargas will share strategies for successfully navigating evolving manufacturing workflows, processes, and technologies for RNA vaccines and therapies, including:

• Insights into the opportunities and challenges of navigating the complexity and diversity of RNA-LNPs
• An overview of the RNA manufacturing process including in vitro transcription (IVT), tangential flow filtration (TFF), and encapsulation workflows
• Scale-up, analytical, and facility considerations to streamline GMP manufacturing of RNA-LNPs and enable production for different stages of clinical development

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.