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.