Pre-Con Workshop Day (27th April 2026) - CET/CEST (Cent Europe Summer, GMT+2)
Addressing the root causes of high viscosity in mAb and novel protein formations
Strategies for screening to modulate protein to protein interactions
Reducing viscosity whilst maintaining stability
Navigating the interplay between formulation properties, device functionality, and manufacturability
Mitigating risk from interfacial stress during processing & shipping
Utilising advanced techniques and modelling to screen for aggregation early on
Investigating sub-visible particle formation
Implementing robust control strategies
Transitioning from a conventional filling line to a gloveless robotic isolator process
Reducing human error
Enhancing sterility assurance
Enabling multi-product facility flexibility
Overcoming validation & regulatory compliance hurdles for automated filling systems
Eliminating washing & sterilisation steps by leveraging RTU primary packaging
Simplifying manufacturing footprint
Reducing validation burden
Best practices for qualifying RTU components
Managing suppliers to ensure quality consistency
Accelerating the path to patients with RTU systems
Maintaining cell viability and functionality throughout manufacturing process: from harvest to final cryopreserved formation
Transitioning from manual, open processes to fully closed and automated fill-finish platforms
Improving batch consistency and reducing contamination risk
Optimising cryopreservation media and freezing protocols to ensure high cell recovery and post-thaw potency
Strategies to address vein-to-vein logistics hurdles
- Dzulija Kuzmenko - Sr. Scientist Biologics AD, Johnson and Johnson Innovative Medicines
- Rifat Kamarudheen - MSAT Emerging Tech Sr Scientist, Johnson and Johnson Innovative Medicines
Device Integration: Connecting formulation science with patient-centric delivery systems. How do you design a formulation for an auto-injector from day one?
Aseptic Processing: How to approach and maintain aseptic conditions throughout final fill-finish stages to enhance safety?
Make vs. Buy: A strategic framework for navigating the fill-finish CDMO landscape. When should you build capacity, and how do you select the right partner?
The Regulatory Horizon: Preparing for future expectations in aseptic processing, data integrity, and the use of AI in manufacturing.
Sustainability: Addressing the growing need for sustainable and PFAS-free consumables in fill-finish operations.
