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Description
As we approach the first anniversary of the launch of the FDA’s Novel Excipient Review Pilot Program, join us for an exciting two-part event focused on excipient innovation. Part one is described below. For information on part two (and registration bundling options) visit our event page: Modernizing Excipient Technology - Need for excipients designed for purpose
Save when you register your team! Contact Courtney Nazareno to take advantage of our "Buy 4 get 1 Free" offer.
Delivery of nucleic acids using lipid nanoparticles: Role of lipids
Presented by: Jay Natarajan
Lipid nanoparticles (LNP) have shown great promise for delivery of nucleic acids – including DNA, siRNA, and mRNA, thanks to the recent approvals of COVID-19 vaccines. Beyond vaccines, LNP are considered as a gold standard for gene and cell-based therapies. The success of an LNP delivery system is highly dependent on the formulation design for enhanced efficacy and safety. In this presentation, we will review the role of individual functional excipients that are typically included in the LNP formulation. A case study shall be presented and discussed for one of the excipients, namely cholesterol. In addition, we will discuss the recent developments of LNPs in vaccines and beyond with closing remarks on current challenges and a future outlook.
The Evolution of Vaccines Technology
Presented by: Jennifer Sloan
This presentation reviews the progression of mRNA-based vaccines, their potential future applications, and the historical evolution of various vaccine technology. The pros and cons of different types of vaccines available today are reviewed. Clinical trial structure for vaccines and other considerations such as multiple doses and storage conditions are also discussed.
Novel Lipid Nanoparticle Platform Enables RNA Delivery for Vaccines and Other Applications in Genetic Medicine
Presented by: Samuel Clarke
RNA can be designed to silence, express, and edit specific genes providing a flexible and powerful approach to treating disease. However, RNA are large molecules that require nanoparticles for delivery to target tissues and cells. Precision NanoSystems has developed a lipid nanoparticle (LNP) platform and a microfluidic-based manufacturing platform. The LNP platform leverages a library of proprietary lipids for making unique LNP formulations that encapsulate RNA. The microfluidic platform is designed for rapid development and scalable manufacture of RNA-LNPs, enabling progression from lab scale (mL) to GMP manufacturing (litres) within weeks or months. In this talk, we will showcase data in the areas of RNA vaccines and ex vivo cell therapies to demonstrate the versatility of these platform technologies to accelerate development of genetic medicines.