Aldevron Breakthrough Blog
Webinar: Comprehensive GMP Manufacturing of mRNA-LNP Drug Products
August 9, 2023 / by Aldevron
Streamlining the mRNA manufacturing process from Sequence-to-Vial
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 final 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, Comprehensive GMP Manufacturing of mRNA-LNP Drug Products: Streamlining the mRNA manufacturing process from Sequence-to-Vial, Yasser Kehail, Senior Manager, Product & Business Management for mRNA, highlights 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. He discusses the significance of delivering a comprehensive CMC package under a single manufacturer to help simplify a complex process.
In the next segment, Lloyd Jeffs, Ph.D., Senior Director of BioPharma Services at Precision NanoSystems (PNI), focuses on PNI’s Genomic Medicine Toolbox for end-to-end development of RNA-lipid nanoparticles (RNA-LNP), highlighting the nanoparticle delivery and the NxGEN
Overall, 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. Webinar attendees also had the opportunity to ask Kehail and Jeffs about this comprehensive approach during the Q&A following the presentation.
- Want to learn more? Contact us with questions on this topic
- Preparing to do an mRNA production run? Read Todd Howren’s post on readiness
- Visit the mRNA page of our website
- Have a topic to suggest? Let us know
Aldevron
Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in cGMP manufacturing and is known for inventing the GMP-Source® quality system. Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world at company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Lincoln, Nebraska.