2nd mRNA & CGT: CMC, Process Development and Manufacturing

The 2nd mRNA & CGT: CMC, Process Development and Manufacturing Summit is the definitive event for industry leaders focused on advancing the science and manufacturing of mRNA and cell & gene therapies (CGTs). Bringing together experts from biotech, pharma, regulatory agencies, and academia, this summit offers an unparalleled platform to address the technical, regulatory, and operational challenges shaping the future of advanced biologics.

Key Themes & Trends

As mRNA and CGT products rapidly transition from discovery to commercial production, the summit explores innovations in CMC strategies, including process development, scale-up, and manufacturing optimization. Attendees will engage with cutting-edge topics such as:

• Modular and automated manufacturing platforms
• Advances in lipid nanoparticle (LNP) formulation and delivery
• Innovations in plasmid DNA (pDNA) production and in-vitro transcription (IVT)
• Application of digital tools and process analytical technology (PAT) to improve process control and real-time monitoring

Challenges & Practical Insights

The summit dives deep into addressing industry pain points such as raw material variability, supply chain resilience, and tech transfer complexities. Expert-led sessions will focus on:

• Ensuring consistent product quality and purity across scale-up
• Developing and validating robust analytical methods for potency, identity, and stability
• Navigating evolving regulatory expectations and accelerating approvals through quality by design (QbD)
• Managing comparability studies and lifecycle management of mRNA and CGT products

Networking & Collaboration

Beyond technical learning, the event fosters collaboration among scientists, engineers, regulatory specialists, and business leaders. It provides a unique forum to benchmark solutions, share best practices, and build partnerships critical to advancing mRNA and CGT therapies from pipeline to patient.

Whether your role spans early development, clinical manufacturing, regulatory affairs, or commercial operations, the #EmRNA summit delivers the insights, innovations, and connections essential for success in this rapidly evolving field.