OVERVIEW

3rd mRNA & CGT: CMC, Process Development and Manufacturing is organized by Vonlanthen Group of Companies and will be held from Dec 03 - 04, 2026 in Munich, Bayern, Germany.

Key Practical Learning Points:
CMC, Process Development & Manufacturing Strategy

Build future-proof CMC strategies tailored to mRNA and CGT modalities, incorporating regulatory expectations, platform lifecycle management, and accelerated development pathways.
Implement intensified upstream and downstream processes to increase yield, purity, and scalability for mRNA, LNPs, and viral vectors.

Manufacturing Platforms, Automation & Tech Transfer

Deploy closed, modular, and digitalized manufacturing platforms to improve flexibility, contamination control, and global tech transfer readiness.
Optimize raw material strategies—including nucleotides, enzymes, lipids, and plasmids—to mitigate supply chain risk, variability, and qualification challenges.

Quality, Analytics & Regulatory Expectations

Advance and validate analytical methods for potency, identity, purity, and stability of mRNA, LNP formulations, and gene-modified products.
Address global regulatory updates for CMC dossier requirements, comparability expectations, platform-based submissions, and evolving RNA-specific guidance.

Formulation, LNP Technologies & Next-Gen Constructs

Design and scale LNP formulations with improved reproducibility, encapsulation efficiency, release profiles, and in vivo performance.
Explore next-generation mRNA constructs, self-amplifying systems, circular RNA, and emerging delivery technologies to enhance expression, stability, and therapeutic effect.

Digitalization, PAT & Real-Time Process Control

Integrate digital tools, automation, AI-driven analytics, and PAT (Process Analytical Technology) to enable real-time monitoring, control, and decision-making during GMP manufacturing.
Ensure process comparability across batches, sites, and scale changes using risk-based strategies, robust control frameworks, and strong data governance.
Ensure comparability across batches and process changes, including best practices for bridging data and risk-based approaches
Explore next-generation mRNA constructs and delivery technologies poised to improve expression, stability, and therapeutic impact