OVERVIEW

GENAP Summit 2026 is organized by EPM Group and will be held from Feb 11 - 12, 2026 in Vienna, Wien, Austria.

Description:
The GENAP Summit 2026 returns as a premier platform for advancing pharmaceutical manufacturing, aseptic processing, and Gene & Cell Therapy (GCT) innovations. As the industry accelerates toward automation, regulatory transformation, and breakthrough therapies, GENAP 2026 will provide unparalleled insights, case studies, and forward-thinking discussions.

This year’s unified program will explore the intersection of aseptic processing and GCT, covering key areas such as bioprocessing, viral vector manufacturing, regulatory compliance, and next-generation automation. Key topics include:

Aseptic Processing & Advanced Manufacturing
- Innovations in contamination control, cleanroom technology, and gloveless isolators
- Annex 1 updates and their impact on aseptic production strategies
- Automated fill-finish solutions and next-gen sterile manufacturing
Gene & Cell Therapy: CMC, Viral Vectors & Bioprocessing
- Optimizing CMC analytics for robust and scalable GCT production
- Overcoming challenges in viral vector manufacturing and process intensification
- Advanced bioprocessing strategies to improve yield, scalability, and regulatory compliance
Pharma 4.0 & Robotics in Manufacturing
- The role of AI, digital twins, and robotics in aseptic processing and ATMP production
- Automation-driven GMP compliance and data-driven decision-making
- The future of modular, flexible, and AI-powered biopharma facilities
Regulatory & GMP Compliance in Aseptic & ATMPs
- Annex 1 compliance strategies for sterile and ATMP manufacturing
- Environmental monitoring, process validation, and risk management
- Navigating the complex regulatory landscape for gene and cell therapies