Thorsten Haefner

VP Business Development PSM

Workshop Day - Monday 23rd March 2026

4:30 PM SPONSORED WORKSHOP C: The Evolution of Fill & Finish Technologies Under EU GMP Annex 1: Transitioning from Traditional Bulk Lines to Human-Free Robotic Aseptic Filling for Orphan and Biological Medicines

As the complexity and sensitivity of biological and orphan medicines continue to rise, the sector faces increasing pressure to modernise aseptic fill & finish operations. This workshop will examine the technological and regulatory transformation driven by the updated EU GMP Annex 1, highlighting the limitations of traditional filling lines and the rapid move towards fully automated, human-free robotic systems designed to protect product integrity and enhance yield. Participants will gain insight into how forward-looking CDMOs are adapting equipment, processes, and facility design to meet the next generation of aseptic standards.

Topics Covered:

Why many CDMO filling lines do not meet the process and contamination-control requirements of modern biological products.
Key machine and process considerations necessary for compliance with the revised EU GMP Annex 1, including contamination control strategies, advanced environmental monitoring, and isolator-based technologies.
A look at the filling lines of the future—advanced robotic platforms enabling human-free aseptic production for high-value, small-batch biologics and orphan medicines.
How cutting-edge fill & finish systems reduce product loss, improve yield, and provide greater operational flexibility.

Three Key Takeaways:

Why traditional lines fall short: Understand the process, product, and contamination-control limitations that make many existing CDMO lines unsuitable for today’s biological medicines.
What Annex 1 truly requires: Gain clarity on the essential machine, process, and environmental design elements needed to achieve compliance with the latest EU GMP Annex 1 expectations.
How robotic lines deliver superior performance: Learn how fully automated, human-free aseptic technologies can enhance product yield, minimise losses, and improve sterility assurance for high-value biological and orphan products.

Check out the incredible speaker line-up to see who will be joining Thorsten.

Download The Latest Agenda

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QUESTIONS?

Address: IQPC Ltd, 129 Wilton Road,
London SW1V 1JZ
Telephone: +44 (0) 1135 210 042
Fax: 44 (0) 207 368 9301
Email: enquire@iqpc.co.uk