Navigating the regulatory and manufacturing realities of mRNA therapeutic development
The increasingly dynamic and multifaceted landscape of mRNA therapeutics is posing new regulatory and manufacturing challenges. Both startups and established biopharma companies require innovative solutions to help them meet the current demand and plan for the next generation of personalized cancer therapies, vaccines, and other mRNA-based therapeutics.
In this GEN webinar, a panel of industry experts will explore the evolution of mRNA technology and the innovations that are driving the conversation around manufacturing setups and regulatory decisions. During the webinar, panelists will cover diverse aspects of manufacturing optionality, including process considerations, scale, automation, digital tools, and facility design. They’ll analyze how these factors vary between different therapies and explain how they are shaping the manufacturing approach for small and large biopharma companies. They’ll also discuss regulatory considerations for mRNA manufacturing and share their perspectives on managing manufacturing needs from early-stage clinical trials to full-scale production.
Key learnings from the webinar include:
- The impact of equipment and technology including automation on the efficiency and scalability in mRNA manufacturing
- Important regulatory considerations in mRNA manufacturing from both the supply and customer viewpoints
- How flexible solutions helps drug developers successfully navigate the unique funding and developmental timelines of their mRNA projects
Presenters:
Ola Tuvesson
Chief Technology Officer, NorthX Biologics
Katarina Stenklo
Sr. Product Manager, Global FlexFactory, Cytiva
Sandra Racordon-Pape
Head of Regulatory Science, Cytiva
Joe Barberio
Vice President Technical Operations, Strand Therapeutics
Register to listen on demand here.
About NorthX Biologics AB
NorthX Biologics is a CDMO and Innovation Hub in Advanced Biologics, with +30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cells and other advanced biologics. Headquartered in the heart of Sweden, the team serves customers worldwide and in 2021 was recognized as a national innovation hub for advanced therapeutics and vaccines. NorthX has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies.
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