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

2nd mRNA & CGT Summit Concludes Successfully in Vienna, Advancing CMC and Manufacturing Excellence

Vienna, Austria – November 26, 2025 — The 2nd mRNA & CGT: CMC, Process Development and Manufacturing Summit, held on November 25–26, 2025, successfully brought together senior experts from biotech, pharmaceutical companies, CDMOs, and academia for two days of in-depth knowledge exchange and practical discussion focused on the development and manufacturing of advanced therapies.

The summit delivered a highly technical and application-driven agenda, addressing critical challenges across CMC strategy, process development, scale-up, formulation, analytical methods, quality control, and regulatory readiness for mRNA and cell & gene therapy products. Through real-world case studies and expert-led sessions, attendees gained actionable insights into optimizing mRNA production platforms, managing raw material variability, implementing closed and modular manufacturing systems, and ensuring comparability throughout product lifecycle changes.

A strong emphasis was placed on regulatory expectations, with practical guidance on CMC dossier requirements, tech transfer strategies, and risk-based approaches to batch bridging and process changes. Sessions on LNP formulation, PAT implementation, and next-generation mRNA technologies further highlighted the industry’s rapid evolution toward more robust, scalable, and reproducible manufacturing models.

The event attracted a senior, cross-functional audience, with the majority representing CMC, process development, manufacturing, analytical development, quality, and regulatory functions, reinforcing the summit’s role as a focused platform for decision-makers driving early-stage innovation through to commercial manufacturing.

We would like to extend our sincere thanks to all speakers for sharing their expertise, real-world experience, and valuable perspectives, which were central to the success and technical depth of the event. Our gratitude also goes to our sponsors and partners for their continued support and contribution to meaningful industry collaboration and innovation.

Following the strong engagement, high-quality discussions, and positive feedback from participants, plans are already underway for the next edition of the mRNA & CGT Summit, continuing to support collaboration and progress in advanced therapy development.

Professionals interested in future editions are encouraged to follow #EtapaPharma for updates and early registration opportunities.

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