Smart Technology, Skilled Teams: Building Agile Aseptic Operations
Day 3 Next-Gen Bio Stage
08/10/2026 11:30 - 11:55am
Contributors
Brent Lieffers : Sr. Director of Innovation Advocacy - Cytiva
Magnus Gustafsson : Chief Commercial Officer - NorthX Biologics
Biologic drugs, including advanced therapies and personalised medicines, are evolving fast. But manufacturing infrastructure is struggling to keep up. An increasing number of companies outsource to CDMOs. At the same time, highly complex products and small batch sizes are becoming the norm. Closing this gap takes more than new equipment. It demands regulatory-ready technology, skilled teams, and strong collaboration across the ecosystem.
In this session, NorthX Biologics shares how they redesigned aseptic fill-finish. Their goal was to support small, customised batches while staying scalable and inspection-ready. To help them get there, they used a closed, automated, gloveless isolator. This flexible setup helped them qualify quickly, reduce reliance on operators, and speed up the path from lab to clinic.
They will share their qualification and validation approach, contamination control strategy, and key insights from engaging with regulators in the use of gloveless isolators.