Comprehensive GMP Manufacturing of mRNA-LNP Drug Products: Sequence-to-Vial

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The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process requiring a high degree of expertise, capabilities, and experience. The development and manufacturing of drug product involves several stages that include production of cell banks, linear DNA, and mRNA drug substance, with lipid nanoparticle (LNP) formulation/encapsulation and analytical testing at all steps, through aseptic fill/finish.

In the first segment of this webinar, we will highlight Aldevron’s newly expanded sequence-to-vial mRNA ecosystem, providing a streamlined service in the development, production, and release of both mRNA drug substance and drug product, which includes LNP encapsulation and aseptic fill-finish capabilities. We will detail the significance of delivering a comprehensive CMC package under a single manufacturer to help simplify this complex process.

Next, the webinar will focus on Precision Nanosystems (PNI)’s Genomic Medicine Toolbox for end-to-end development of RNA-lipid nanoparticles (RNA-LNP), highlighting the nanoparticle delivery and the micro fluidics-based nanoparticle manufacturing platforms. We will provide examples of how these platform technologies are enabling drug developers to rapidly discover new RNA-LNP based vaccines, gene therapies, and cell therapies. This presentation highlights seamless access to pharmaceutical-grade RNA-LNP drug product for clients and partners under a single ecosystem, minimizing the logistical complexity of multiple vendors that leads to major risks for RNA program success.

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

Produced with support from:

Product & Business Management Aldevron

Senior Director of BioPharma Services Precision NanoSystems