AGENDA AT A GLANCE
8:30
Registration & Coffee
8:55
Chairman’s Welcome Note
Ireland’s Biologics Manufacturing Landscape: Scaling for 2030
9:00
Capacity vs Capability: What Will Define Ireland's Next Phase of Biomanufacturing Growth?
- Balancing facility expansion with advanced manufacturing capabilities
- Preparing for increasingly complex biologics and next-generation modalities
- Building operational flexibility to support changing portfolio demands
- Lessons learned from recent manufacturing investments and expansions
9:25
Reserved for Solution Provider
9:50
Executive Panel: What Will Ireland Need to Remain a Global Biologics Manufacturing Leader?
- Talent and workforce challenges
- Future manufacturing technologies and digitalisation
- Infrastructure and utility requirements
- Competing with emerging manufacturing regions
10:15
Networking Break
Upstream Processing Excellence: High-Titre, High-Efficiency Cell Culture
11:00
Pushing Cell Culture Limits: Achieving Higher Titres Without Compromising Process Robustness
- Strategies for increasing productivity while maintaining product quality attributes
- Managing process variability and cell health at ultra-high titres
- Balancing yield improvements with downstream processing capabilities
- Lessons learned from commercial implementation of high-performance cell culture platforms
11:25
Reserved for Service Provider
11:50
Upstream Intensification in Practice: Delivering More Product from Existing Assets
- Implementing intensified cell culture strategies at commercial scale
- Evaluating fed-batch, perfusion, and hybrid manufacturing approaches
- Managing the downstream impact of increased upstream productivity
- Assessing the business case for process intensification investments
12:15
Lunch Break
Downstream Processing Innovation
13:15
Continuous & Intensified Downstream Processing: Driving Efficiency at Commercial Scale
- Evaluating the readiness of continuous downstream technologies for commercial manufacturing
- Maximising resin utilisation, productivity, and process economics
- Integrating intensified purification strategies into existing manufacturing facilities
- Overcoming technical, operational, and regulatory implementation challenges
14:00
Reserved for Solution Provider
14:25
Downstream Processing in the Era of High-Titre Manufacturing
- Managing the impact of increasing upstream yields on purification capacity
- Addressing resin, filtration, and chromatography constraints
- Maintaining product quality while increasing process throughput
- Strategies for future-proofing downstream operations
14:50
Networking Break
16:00
Roundtable Discussions
- What Will Define the Next Generation of Antibody-Based Therapeutics?
- How Can Industry Accelerate ADC Development While Managing Cost and Complexity?
- Are Current Manufacturing Technologies Ready for the Future ADC Pipeline?
- Balancing Innovation, Scalability and Commercial Viability in Antibody Therapeutics
16:30
Key Takeaways
16:45
Drink Reception & End of Day 1
8:30
Registration & Coffee
8:55
Chairman’s Welcome Note
Automation, Robotics & the Digitally Enabled Biologics Plant
9:00
Digital GMP in Practice: Ensuring Compliance in Highly Automated Environments
- Navigating regulatory expectations for digital and automated manufacturing systems
- Ensuring data integrity across interconnected platforms and manufacturing technologies
- Implementing effective validation strategies for digital tools, AI and automation solutions
- Lessons learned from maintaining inspection readiness in highly automated facilities
9:25
Reserved for Solution Provider
9:50
Digital Twins & Simulation: Optimising Process Design, Tech Transfer & Scale-Up
- Applying digital twins to support process development and commercial manufacturing
- Predicting process variability and identifying optimisation opportunities before scale-up
- Accelerating technology transfer through virtual process modelling and knowledge sharing
- Integrating digital twin platforms with manufacturing and operational data systems
10:15
Networking Break
CMC Strategy for Accelerated Development & Commercialisation
10:45
Achieving Commercial Readiness: Key CMC Considerations for Late-Stage Biologics
- Ensuring manufacturing readiness ahead of regulatory submissions
- Aligning process validation and control strategies with commercial requirements
- Mitigating technical risks during technology transfer and scale-up
- Building sustainable supply strategies for product launch
11:10
Reserved for Service Provider
11:35
Panel Discussion - Drug Product Challenges in Manufacturing Novel Biologics
- Stability challenges in increasingly complex biologics
- Managing viscosity and aggregation in high-concentration formulations
- Device compatibility and patient-centric delivery systems
- Improving commercial manufacturability through earlier formulation decisions
12:00
Lunch Break
Strategic Supply Chain Management
13:00
Managing Supply Chain Volatility in Biologics Manufacturing
- Addressing longer lead times for critical materials and consumables
- Managing geopolitical risks and logistics disruptions
- Building flexibility into procurement and production planning
- Strengthening supplier relationships to improve supply security
13:45
Raw Material Security & Single-Use Supply Strategies
- Managing risks associated with critical raw materials
- Securing supply of single-use technologies
- Balancing cost pressures with resilience objectives
- Long-term sourcing strategies for biologics manufacturing
14:10
Networking Break
14:40
Breaking Down Silos: Connecting Development, Manufacturing, Quality & Supply Chain
- Integrating commercial realities into early development decisions
- Improving collaboration across technical and operational functions
- Reducing downstream manufacturing challenges through earlier alignment
- Building a lifecycle approach to biologics development
Strategic Supply Chain Management
15:05
Bridging the Talent Gap: Building a Future-Ready Biomanufacturing Workforce in Ireland
- Developing the technical and digital skills required for next-generation biologics manufacturing
- Attracting and retaining talent in an increasingly competitive biopharma landscape
- Strengthening collaboration between industry, academia, and training institutions
- Preparing the workforce for AI, automation, and advanced manufacturing technologies
15:30
Future Facility Design: Flexible, Modular & Multi-Product Biologics Plants
- Designing facilities that can support multiple products, modalities, and manufacturing scales
- Leveraging modular and flexible infrastructure to accelerate expansion and technology adoption
- Balancing operational efficiency, sustainability, and future capacity requirements
- Building facilities that can adapt to evolving process, regulatory, and marke
15:55
Chairman's Closing Remarks
16:00
END OF CONFERENCE
