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
Panel Discussion - Doing More with Less: The Next Era of Efficient Biomanufacturing
- Scaling manufacturing while reducing energy, water and material consumption
- Leveraging digitalisation and automation to maximise operational efficiency
- Embedding sustainability into facility design and day-to-day operations
- Balancing productivity, resilience and environmental responsibility
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
15:30
Roundtable Discussions
- Topic- Sustainability in operations (TBC)
- Discussion on statistical models across development to commercial
- Strategies to Reduce Energy Costs Without Compromising GMP Quality
- Process Integration: Connecting Upstream & Downstream for End-to-End Efficiency Gains
- The Future of Technological Teams: Human Expertise vs. AI Skills How we implement statistical models for stability/use it to control our manufacturing/ submission of CMC
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
Designing CMC Strategies That Support Global Commercialisation
- Aligning CMC strategy with global regulatory expectations
- Building scalable and commercially viable manufacturing processes
- Integrating development, MSAT and manufacturing for seamless execution
- Managing risk while accelerating product commercialisation
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
Novel Approaches to Biosafety Testing
13:00
Contamination Control for Complex and Next-Generation Biologics
- Identifying emerging contamination risks across complex biologics processes
- Strengthening contamination-control strategies from development through commercial manufacturing
- Integrating biosafety risk assessment into process design and scale-up
- Improving collaboration between manufacturing, QC microbiology and QA teams
13:25
Reserved for BioReliance
13:50
Future-Proofing Biosafety Testing for Irish Manufacturing Growth
- Scaling biosafety-testing capacity alongside site and portfolio growth
- Building specialist QC microbiology and biosafety-testing expertise
- Increasing testing resilience across internal sites and external partners
- Preparing quality-control systems for evolving modalities and regulatory expectations
14:15
Networking Break
Strategic Supply Chain Management
14:45
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
15:10
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
15:10
Future-Ready Supply Networks: Aligning Capacity, Facilities & Supply Strategy for Long-Term Growth
- Aligning manufacturing capacity and facility investments with future product and market demand
- Building flexibility across internal sites, external partners and supply networks
- Using network planning to reduce supply risk as portfolios and production requirements evolve
- Preparing supply operations for new technologies, changing product formats and commercial growth
16:05
Chairman's Closing Remarks
16:10
END OF CONFERENCE
